WO2017159234A1 - Apparatus for producing eccentric balloon catheter and method for producing eccentric balloon catheter - Google Patents

Apparatus for producing eccentric balloon catheter and method for producing eccentric balloon catheter Download PDF

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Publication number
WO2017159234A1
WO2017159234A1 PCT/JP2017/006368 JP2017006368W WO2017159234A1 WO 2017159234 A1 WO2017159234 A1 WO 2017159234A1 JP 2017006368 W JP2017006368 W JP 2017006368W WO 2017159234 A1 WO2017159234 A1 WO 2017159234A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter tube
pressing
catheter
eccentric
Prior art date
Application number
PCT/JP2017/006368
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French (fr)
Japanese (ja)
Inventor
木村　仁
Original Assignee
日本ゼオン株式会社
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Publication date
Application filed by 日本ゼオン株式会社 filed Critical 日本ゼオン株式会社
Priority to JP2018505379A priority Critical patent/JP6984589B2/en
Publication of WO2017159234A1 publication Critical patent/WO2017159234A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to an eccentric balloon catheter manufacturing apparatus and a method of manufacturing an eccentric balloon catheter in which a balloon is eccentric with respect to the axis of the catheter tube and expands.
  • a balloon catheter may be used when a calculus (gallstone) generated in the bile duct is removed from the body and removed.
  • a calculus gallstone
  • an eccentric balloon catheter in which the balloon is eccentrically inflated with respect to the axis of the catheter tube is proposed in addition to the balloon inflating concentrically with respect to the catheter tube.
  • An eccentric balloon catheter can scrape stones more efficiently than a balloon that bulges concentrically, and is preferably used when removing stones.
  • an eccentric balloon catheter for example, a member in which a member for regulating the expansion of a part of the balloon in the circumferential direction, such as a fixing tape, is fixed to the catheter tube has been proposed.
  • the eccentric balloon catheter of the type in which an inflation regulating member for regulating the inflation of the balloon is attached from above the balloon is likely to cause variations in the bonding strength of the inflation regulating member as long as it is manufactured by a conventional manufacturing method. It is difficult to increase
  • the present invention has been made in view of such a situation, and an object of the present invention is to provide an eccentric balloon catheter manufacturing apparatus capable of manufacturing an eccentric balloon catheter in which the bonding strength of an expansion regulating member that regulates inflation of the balloon is stable, and its It is providing the manufacturing method of such an eccentric balloon catheter.
  • an eccentric balloon catheter manufacturing apparatus comprises: An apparatus for manufacturing an eccentric balloon catheter in which a balloon is eccentric and expands with respect to the axis of a catheter tube, The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon.
  • An expansion restricting member that restricts a part of the circumferential direction from being separated from the catheter tube;
  • a pressing part that is movable relative to and away from the groove part from the opening side of the groove part, and that presses the expansion regulating member toward the catheter tube;
  • a detection unit that detects a pressing force by the pressing unit.
  • the eccentric balloon catheter manufacturing apparatus has a detection unit that detects a pressing force when the expansion regulating member disposed on the clamp table is pressed toward the catheter tube, the manufactured eccentric balloon is manufactured.
  • the joint strength of the expansion regulating member in the catheter can be stabilized. That is, according to such a manufacturing apparatus, by adjusting the pressing force to an appropriate range based on the detection result, the size of the gap formed between the expansion regulating member and the balloon or catheter to be joined, Since it is possible to stabilize the expansion of the connecting portion formed between the expansion restriction member and the object to be joined, the joint strength of the expansion restriction member in the manufactured eccentric balloon catheter can be stabilized.
  • the pressing force is detected by the detection unit, it is possible to appropriately adjust the pressing force when pressing the expansion regulating member toward the catheter tube even if the operator is not an expert. By using such an eccentric balloon catheter manufacturing apparatus, efficient manufacturing is possible.
  • the pressing parts are arranged at a predetermined interval along the extending direction of the groove part, and the pressing part presses the expansion regulating member toward the catheter tube on the distal end side of the balloon.
  • You may have a 1 press part and the 2nd press part which presses the said expansion control member toward the said catheter tube in the proximal end side from the said balloon.
  • the expansion regulating member can be efficiently joined to the catheter tube at two locations straddling the balloon in the axial direction. That is, according to such a manufacturing apparatus, since the expansion regulating member can be reliably bonded to the catheter tube and can be pressed simultaneously at two locations, workability is also good.
  • the detection unit is disposed between the pressing unit and a pressing force transmission unit that transmits a pressing force to the pressing unit, and relative to the pressing unit according to a reaction force transmitted from the pressing unit.
  • You may have a deformation
  • a manufacturing apparatus having a deforming portion that deforms in the relative movement direction of the pressing portion and a display portion that displays the pressing force of the pressing portion adjusts the pressing force on the expansion regulating member to an appropriate range more easily by the manufacturing operator. Therefore, the joint strength of the expansion regulating member in the manufactured eccentric balloon catheter can be further stabilized.
  • the deforming portion may have a compression spring, a pneumatic spring, or a hydraulic spring.
  • the deforming part is not particularly limited as long as it deforms according to the reaction force transmitted from the pressing part.
  • the deforming part may include a compression spring, a pneumatic spring, a hydraulic spring, and the like. The pressing force against the regulating member can be adjusted more accurately.
  • the manufacturing method of the eccentric balloon catheter according to the present invention is a manufacturing method of an eccentric balloon catheter in which the balloon is eccentric and inflated with respect to the axis of the catheter tube, The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon.
  • an eccentric balloon catheter having an expansion regulating member bonded with a stable adhesive strength.
  • FIG. 1 is a schematic diagram illustrating an example of an eccentric balloon catheter manufactured by a manufacturing apparatus according to an embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional view of the eccentric balloon catheter shown in FIG.
  • FIG. 3 is a schematic cross-sectional view of the eccentric balloon catheter taken along line III-III shown in FIG.
  • FIG. 4 is a schematic perspective view showing an eccentric balloon catheter manufacturing apparatus according to an embodiment of the present invention.
  • FIG. 5 is a partially enlarged view of the manufacturing apparatus shown in FIG. 6 is a perspective view of a clamp base included in the manufacturing apparatus shown in FIG. 7 is a schematic plan view showing a catheter tube, a balloon, and an expansion regulating member installed on a clamp base in the manufacturing apparatus shown in FIG.
  • FIG. 8 is a conceptual diagram showing a manufacturing method of the eccentric balloon catheter by the manufacturing apparatus shown in FIG.
  • FIG. 9 is a flowchart showing an example of a manufacturing process of the eccentric balloon catheter by the manufacturing apparatus shown in FIG.
  • FIG. 10 is a graph showing the result (level 1) of the peeling test in the example.
  • FIG. 11 is a graph showing the result (level 2) of the peeling test in the example.
  • FIG. 12 is a graph showing the result (level 3) of the peeling test in the example.
  • FIG. 1 is a schematic view showing an example of an eccentric balloon catheter 1 manufactured by a manufacturing apparatus according to an embodiment of the present invention.
  • the eccentric balloon catheter 1 has a catheter tube 5, a balloon 2, and a belt-like body 20 as an expansion regulating member.
  • the balloon 2 swells eccentrically with respect to the axis of the catheter tube 5.
  • the catheter tube 5 is a tube made of a flexible material, and is a tube distal end portion 7 which is an end portion to be inserted into the body and a proximal end portion (not shown) located on the other end side. ).
  • the outer diameter d1 of the catheter tube 5 is, for example, about 1 to 3 mm, and the total length can be about 500 to 2500 mm, but is not particularly limited.
  • the size of the catheter tube 5 depends on the use of the eccentric balloon catheter 1 and the like. As appropriate.
  • the material of the catheter tube 5 is not particularly limited as long as it is a flexible material, but is preferably a polymer material, and particularly preferably a polyamide resin or a polyamide-based elastomer.
  • a balloon lumen 8, a contrast medium lumen 9, and a guide wire lumen 10 are formed inside the catheter tube 5.
  • the balloon lumen 8 is a lumen serving as a flow path for sending a fluid such as air used to inflate the balloon 2 to the internal space 24 of the balloon 2.
  • the balloon lumen 8 extends from the proximal end of the catheter tube 5 to the middle of the tube distal end 7 which is the distal end of the catheter tube 5, and is provided so as to open into the internal space 24 of the balloon 2. Is connected to the fluid outlet 11.
  • the contrast medium lumen 9 is a lumen used as a contrast medium channel when performing X-ray contrast in the body for the purpose of confirming the position of the calculus.
  • the contrast medium lumen 9 penetrates from the proximal end of the catheter tube 5 to the spout 12 at the distal end portion 7 of the catheter tube 5.
  • the spout 12 is an opening provided so as to be positioned closer to the proximal end than the balloon 2.
  • the spout may be an opening provided so as to be located on the distal end side of the balloon 2.
  • the guide wire lumen 10 is a lumen through which the guide wire is inserted when the eccentric balloon catheter 1 is inserted into the body along the guide wire, and penetrates from the proximal end of the catheter tube 5 to the distal end opening 10a. Yes.
  • the contrast medium lumen and the guide wire lumen 10 are not necessarily provided, and other lumens having functions other than the functions described above may be formed.
  • the cross-sectional shapes of the balloon lumen 8, the contrast medium lumen 9, and the guide wire lumen 10 are not limited, and may be shapes that can be efficiently arranged in the catheter tube 5.
  • the guide wire lumen 10 preferably has a circular cross-sectional shape.
  • the sectional area of the balloon lumen 8 is, for example, 0.03 to 0.3 mm 2
  • the sectional area of the contrast medium lumen 9 is, for example, 0.08 to 0.8 mm 2
  • the sectional area of the guide wire lumen 10 is, for example, 0.5 to 1.
  • the cross-sectional area of each lumen is not particularly limited, and can be appropriately changed according to the outer diameter of the catheter tube and the like.
  • the balloon 2 of the eccentric balloon catheter 1 is attached in the vicinity of the distal end portion 7 of the catheter tube 5 so as to cover the fluid outlet 11 formed in the catheter tube 5.
  • the balloon 2 is formed of a stretchable material, and is inflated by introducing a fluid into the internal space 24 via the balloon lumen 8 of the catheter tube 5. With the inflated balloon 2, a calculus 50 as shown in FIG. 2 can be scraped or pushed out to remove the calculus in the body.
  • the stretchable material forming the balloon 2 is preferably a material having a 100% modulus (measured in accordance with JIS K 6251) of 0.1 to 10 Mpa, particularly preferably 1 to 5 Mpa. If the 100% modulus is too small, the strength of the balloon 2 may be insufficient. If it is too large, the balloon 2 may not be expanded to a sufficient size.
  • Specific examples of the stretchable material suitable for forming the balloon 2 include natural rubber, silicone rubber, polyurethane elastomer, and the like.
  • the balloon 2 has a tubular shape as a whole, and the catheter tube 5 is inserted therethrough, and joint portions 4a and 4b joined to the outer peripheral surface of the catheter tube 5 at both ends thereof. Is formed.
  • the shape of the joint portions 4a and 4b located at both ends of the inflatable portion 3 of the balloon 2 is not particularly limited as long as it can be joined to the outer peripheral surface of the catheter tube 5, but is preferably a cylindrical shape.
  • the inner diameter is preferably substantially equal to the outer diameter of the catheter tube 5, and the length is preferably 0.5 to 5 mm.
  • the thickness of the joint portions 4a and 4b of the balloon 2 is not particularly limited, and may be substantially equal to the inflatable portion 3, for example.
  • the method of joining the joining parts 4a and 4b of the balloon 2 and the outer peripheral surface of the catheter tube 5 is not particularly limited, and examples thereof include adhesion with an adhesive, thermal fusion, welding with a solvent, and ultrasonic welding. be able to.
  • an inflatable portion 3 that is inflated by introducing a fluid into the internal space 24 is formed between the joint portions 4a and 4b.
  • an inflated balloon 2 is shown.
  • the inflated portion 3 of the balloon 2 preferably has a maximum outer diameter in the inflated state of 110 to 200% of the minimum outer diameter in the deflated state. If this ratio is too small, the balloon 2 may not expand to a sufficient size, and if it is too large, the balloon 2 may become an obstacle when the eccentric balloon catheter 1 is inserted into the body.
  • the length of the inflatable portion 3 in the balloon 2 (the length along the axial direction of the catheter tube 5) is preferably 5 to 20 mm, and the wall thickness is preferably 0.10 to 0.50 mm.
  • the wall thickness of the balloon 2 is preferably uniform along the circumferential direction.
  • the method for producing the balloon 2 having the shape as described above is not particularly limited, and a known method may be used as a method for forming the stretchable material, but it is preferable to use a dipping method.
  • a stretchable material and various additives as necessary are dissolved in a solvent to form a solution or suspension, and a mold having an outer shape substantially equal to the desired balloon shape is formed in this solution (suspension). It is immersed and a solution (suspension) is applied to the surface of the mold, and the solvent is evaporated to form a film on the surface of the mold. By repeating this immersion and drying, a balloon having a desired thickness can be formed.
  • crosslinking is performed after film formation, if necessary.
  • the eccentric balloon catheter 1 has a belt-like body 20 as an expansion regulating member.
  • the belt-like body 20 as the expansion regulating member is disposed on the catheter tube 5 and the balloon 2 so that at least a part thereof overlaps the balloon 2, and when the balloon 2 is inflated, a part of the balloon 2 in the circumferential direction is disposed.
  • the separation from the catheter tube 5 is restricted.
  • the belt-like body 20 extends along the axial direction of the catheter tube 5 so as to straddle the balloon 2, and the axial length of the belt-like body 20 is longer than the axial length of the balloon 2.
  • the band-like body proximal end portion 22 b that is the proximal end portion of the band-like body 20 is fixed to the outer peripheral surface of the catheter tube 5 on the proximal end side from the balloon 2, and is a band-like shape that is the distal end portion of the band-like body 20.
  • the body distal end 22 a is fixed to the outer peripheral surface of the catheter tube 5 on the distal end side of the balloon 2.
  • the material of the belt-like body 20 is not particularly limited, and for example, it is made of the same resin as that constituting the catheter tube 5. However, when the balloon 2 is inflated, the band-shaped body 20 regulates the expansion of the balloon 2, and the center of the inflated balloon 2 can be separated from the band-shaped body 20 compared to the center of the catheter tube 5. Is preferably made of a material that is less stretchable than the balloon 2. Moreover, the joining method of the band-like body proximal end 22b and the band-like body distal end 22a and the catheter tube 5 to be joined is not particularly limited, and examples thereof include adhesion, heat fusion, and high-frequency fusion. be able to.
  • the width of the belt-like body 20 is a width of 1/2 or less of the circumferential length on the outer periphery of the catheter tube 5, and preferably a width of 1/3 to 1/5. If the width is too small, the function of restricting the circumferential portion of the balloon 2 from separating from the catheter tube 5 from above the balloon 2 becomes small. If the width is too large, the balloon 2 is sufficiently inflated. It becomes difficult.
  • a band-like body 20 that restricts the circumferential portion of the balloon 2 from being separated from the catheter tube 5 when the balloon 2 is inflated is joined to the catheter tube 5, and is shown in FIG. 3.
  • the expansion portion 3 of the balloon 2 expands eccentrically with respect to the axis of the catheter tube 5.
  • the eccentric amount h1 of the expansion center of the expansion part 3 with respect to the axis of the catheter tube 5 is preferably 50 to 100%, more preferably 75 to 100% with respect to the expansion radius R of the expansion part 3.
  • the balloon 2 does not need to be completely inflated in the cross section, and may be inflated into an elliptical shape or other shapes.
  • contrast rings 26a and 26b are provided at two locations on the outer peripheral surface of the catheter tube 5. As shown in FIG. The contrast ring 26 a is disposed in the internal space 24 of the balloon 2, and the contrast ring 26 b is disposed outside the balloon 2 and in a position close to the joint portion 4 b on the proximal end side of the balloon 2.
  • the contrast rings 26a and 26b are manufactured using, for example, a metal composition such as gold, platinum, or platinum iridium alloy, which is an X-ray opaque material, or a resin composition containing powder of an X-ray contrast material.
  • FIG. 4 is a schematic view showing a pressing device 60 which is a manufacturing apparatus of the eccentric balloon catheter 1 and presses the band-like body 20 which is an object placed on the clamp table 61 against the catheter tube 5.
  • the pressing device 60 includes a pedestal 64, a support column 66 that extends upward from the pedestal 64, and a beam 67 that extends horizontally from the support column and is cantilevered by the support column 66.
  • the pressing device 60 includes a clamp base 61 installed on a base 64 below the beam 67, a pressing force transmission member 68 connected to the beam 67 so as to be relatively movable, and a pressing force transmission member 68. And a pressing portion 69 that is relatively movable so as to approach and separate from the groove portion 62 of the clamp base 61.
  • the pressing device 60 includes a lever 65 for moving the pressing force transmission member 68 and the pressing portion 69 in the vertical direction, and a detection unit 70 for detecting the pressing force by the pressing portion 69.
  • FIG. 7 is a conceptual view of the clamp base 61 and the catheter tube 5 accommodated in the groove 62 of the clamp base 61 as viewed from above.
  • the groove 62 of the clamp base 61 accommodates the vicinity of the tube distal end portion 7 of the catheter tube 5, the balloon 2 joined to the catheter tube 5, and the band-like body 20 before joining to the catheter tube 5.
  • the belt-like body 20 is disposed above the catheter tube 5 and the balloon 2 so as to straddle the balloon 2 along the axial direction of the catheter tube 5.
  • the pressing portion 69 is provided between the pressing force transmitting member 68 at the lower end of the pressing force transmitting member 68 that transmits the pressing force to the pressing portion 69. They are connected with the deformation portion 71 interposed therebetween.
  • the deforming part 71 is composed of a compression spring that is elastically deformed in the vertical direction, which is the relative movement direction of the pressing part 69, and biases the pressing part 69 downward.
  • the pressing portion 69 can move relative to the pressing force transmitting member 68 in the vertical direction, and when the pressing portion 68 receives a reaction force from the belt-like body 20 or the like to be pressed, the deforming portion 71 contracts. As a result, the pressing portion 69 moves upward relative to the pressing force transmission member 68.
  • the pressing part 69 has a first pressing part 69a and a second pressing part 69b arranged at a predetermined interval along the extending direction of the groove part 62 in the clamp base 61.
  • the first pressing portion 69a disposed on the distal end side presses the band-shaped body distal end portion 22a shown in FIG. 7 toward the catheter tube 5, and the second pressing portion 69b disposed on the proximal end side is The band-like body proximal end portion 22 b shown in FIG. 7 is pressed toward the catheter tube 5.
  • the pressing device 60 has a detection unit 70 that detects the pressing force by the pressing unit 69.
  • the detection unit 70 is disposed between the pressing unit 69 and the pressing force transmission member 68, and corresponds to the deformation unit 71 that deforms according to the reaction force transmitted from the pressing unit 69, and the deformation amount of the deformation unit 71.
  • a scale 72 as a display unit for displaying the pressing force.
  • the scale 72 of the detection unit 70 is formed on the surface of the pressing unit 69, and the pressing unit 69 depends on the positional relationship between the lower end 68 a of the pressing force transmitting member 68 that moves relative to the deformation amount of the deformation unit 71 and the scale 72.
  • the pressing force by is displayed.
  • each member included in the pressing device 60 is not particularly limited, but the pedestal 64, the support column 66, the pressing force transmission member 68, the pressing portion 69, and the like are made of metal such as iron or stainless steel from the viewpoint of durability and stability. Preferably it is made of a material.
  • transformation part 71 is produced, for example by hard metals, such as high carbon steel and a stainless steel wire, but it is not specifically limited.
  • the clamp table 61 can be manufactured using a material such as metal or resin, and the material is not particularly limited. For example, it is manufactured by PTFE. Also in this case, it is preferable because it can be easily removed.
  • FIG. 9 is a flowchart showing an example of a manufacturing process of the eccentric balloon catheter 1 using the pressing device 60 shown in FIG.
  • the manufacturing process of the eccentric balloon catheter 1 will be described with reference to FIG.
  • step S001 shown in FIG. 9 the balloon 2 is joined in the vicinity of the distal end portion 7 of the catheter tube 5 shown in FIG. Specifically, the joint portions 4a and 4b of the balloon 2 are fixed to the outer peripheral surface of the catheter tube 5 using an adhesive or the like, or by heat fusion.
  • the contrast rings 26a and 26b are fixed to predetermined positions of the catheter tube 5 with an adhesive or the like before and after step S001.
  • step S002 shown in FIG. 9 the catheter tube 5 to which the balloon 2 is joined in step S001 and the belt-like body 20 are set in the groove portion 62 of the clamp base 61.
  • the catheter tube 5 to which the balloon 2 is joined is disposed in the groove portion 62 of the clamp base 61, and then the belt-like body 20 is disposed on the balloon 2 as shown in FIG.
  • the band 20 is a catheter so that the band distal end 22a and the band proximal end 22b, which are both ends of the band 20, protrude from the distal end side and the proximal end side of the balloon 2. It is arranged with respect to the tube 5.
  • the catheter tube 5, the balloon 2, and the strip 20 disposed in the groove 62 are fixed to the groove 62 using a fixing plate 63 shown in FIG. 6.
  • step S003 shown in FIG. 9 an adhesive for joining the strip 20 to the catheter tube 5 is applied.
  • the band-like body distal end 22a of the band-like body 20 is lifted and an adhesive is applied to the outer peripheral surface of the catheter tube 5 positioned below the band-like body distal end 22a, the band-like body distal end The part 22a is overlaid on the applied adhesive.
  • the strip-like body proximal end portion 22b is also performed in the same manner as the strip-like body distal end portion 22a.
  • a part of the band proximal end 22b is located on the contrast ring 26b, and therefore a part of the adhesive for fixing the band proximal end 22b is It is also applied on the contrast ring 26b.
  • FIG. 8 is a cross-sectional view showing the periphery of the strip-like body distal end portion 22a and the strip-like body proximal end portion 22b in FIG.
  • the adhesive 78b for fixing the band-like body proximal end portion 22b to the catheter tube 5 is preferably disposed at a predetermined interval with respect to the balloon 2 so as not to contact the balloon 2. This is to prevent the expansion of the balloon 2 from being unnecessarily restricted, and to prevent the bonded portion from peeling off as the balloon 2 expands. The same applies to the adhesive 78a for fixing the band-like body distal end portion 22a to the catheter tube 5.
  • step S004 shown in FIG. 9 the strip 20 set in the groove 62 of the clamp base 61 is pressed toward the catheter tube 5.
  • the clamp base 61 on which the catheter tube 5 coated with the adhesive is set in step S ⁇ b> 003 is fixed below the pressing portion 69 in the pressing device 60.
  • the operator of the pressing device 60 rotates the lever 65 shown in FIG. 4 to the front side to move the pressing force transmission member 68 and the pressing portion 69 connected to the lower end of the pressing force transmission member 68 downward. Move.
  • the first pressing portion 69 a and the second pressing portion 69 b of the pressing portion 69 shown in FIG. 5 approach the groove portion 62 from the opening side of the groove portion 62.
  • the first pressing portion 69a and the second pressing portion 69b come into contact with the strip-like body distal end portion 22a and the strip-like body proximal end portion 22b of the strip-like body 20, respectively, thereby causing the strip-like body. 20 and the pressing on the catheter tube 5 are started.
  • the detection unit 70 of the pressing device 60 illustrated in FIG. 5 detects the pressing force, and the operator adjusts the pressing force while viewing the detection result.
  • the deforming portion 71 shown in FIG. 5 contracts in the vertical direction by the reaction force received by the pressing portion 69 being transmitted to the deforming portion 71 and detects the pressing force by the pressing portion 69.
  • the detecting unit 70 changes the relative position between the lower end 68a of the pressing force transmitting unit 68 and the scale 72 as the deforming unit 71 is deformed, and the pressing force by the pressing unit 69 is determined by the positional relationship between the lower end 68a and the scale 72. indicate.
  • step S004 or step S005 the state in which the pressing portion 69 presses the strip 20 toward the catheter tube 5 with a predetermined pressing force may be continued for a certain period of time. The time for which the predetermined pressing force is maintained is appropriately adjusted according to the applied adhesive or the like.
  • step S006 shown in FIG. 9 the adhesive that bonds the strip 20 and the catheter tube 5 is cured.
  • the adhesive applied in step S003 is a moisture-curing type or a solvent volatile type
  • the catheter tube 5 and the band-like body 20 after the completion of step S005 are left in a predetermined environment such as a room for adhesion.
  • the agent is cured.
  • the eccentric balloon catheter 1 shown in FIGS. 1 to 3 can be obtained by the series of steps shown in FIG.
  • the eccentric balloon catheter 1 is manufactured using the pressing device 60 as shown in FIG. 4, the bonding strength between the belt-like body 20 and the catheter tube 5 can be stabilized.
  • the eccentric balloon catheter 1 having the characteristics can be efficiently manufactured. That is, based on the detection result of the pressing force by the detection unit 70 of the pressing device 60, by adjusting the pressing force in the joining process of the strip 20 and the catheter tube 5 to an appropriate range, the strip 20 and the catheter tube 5 Since the width of the gap formed between them and the spread of the cured adhesive layer that joins the strip 20 and the catheter tube 5 can be stabilized, the reliability of joining the strip 20 and the catheter tube 5 is improved. be able to.
  • the pressing device 60 can accurately adjust the pressing force, even when the first pressing portion 69a and the second pressing portion 69b are simultaneously pressed at two places, the pressing force and the variation in the bonding strength related thereto are varied. Therefore, the eccentric balloon catheter 1 can be manufactured efficiently.
  • the pressing device 60 may have different shapes depending on the presence or absence of the contrast ring 26 b between the joining portion formed by the first pressing portion 69 a and the joining portion formed by the second pressing portion 69 b. Adhesives 78a and 78b are appropriately interposed between the joining surfaces, and the joining reliability of the band-like body 20 in the eccentric balloon catheter 1 can be enhanced.
  • the manufacturing method of the eccentric balloon catheter 1 using the pressing device 60 and the pressing device 60 shown in FIGS. 4 to 6 is only one embodiment of the present invention, and the present invention includes many other embodiments. Needless to say.
  • the band 20 is bonded to the outer peripheral surface of the catheter tube 5, but the bonding method of the band 20 is not limited to this, and a part or all of the band 20 is formed. It may be joined to the balloon 2.
  • the expansion regulating member that regulates the inflation of the balloon 2 is the band-shaped body 20, but the expansion regulating member is not limited to the band-shaped band-shaped body 20, and other shapes such as a linear shape, a tube shape, and the like. It doesn't matter.
  • the detection part 70 of the press apparatus 60 shown by embodiment has a compression spring as the deformation
  • the display unit is not limited to the one having the scale 72 as shown in FIG. 2, and may be an electric display unit such as a lamp or a liquid crystal panel, or a mechanical display unit such as a pressure gauge. Good.
  • the pressure device may employ a pressure sensor that converts a mechanical deformation amount into an electric signal as the deformation portion of the detection unit 70.
  • the eccentric balloon catheter 1 manufactured by the pressing device 60 and the manufacturing method using the pressing device 60 is not limited to the eccentric balloon catheter for removing gallstones from the bile duct, and moves stones other than gallstones, An eccentric balloon catheter to be removed or other eccentric balloon catheter may be used.
  • Catheter tube Material nylon elastomer, outer diameter 1.80 to 1.90 mm, length 1950 to 2150 mm Balloon: Material Natural rubber latex, outer diameter 2.14 to 2.30 mm when contracted, length 10.5 to 11.5 mm, film thickness 0.17 to 0.25 mm Strip: Material Nylon elastomer, length 13.5 to 14.5 mm, width 1.3 to 1.7 mm, thickness 0.15 to 0.25 mm Adhesive: Type Cyanoacrylate adhesive, 1 to 2 drops (per 1 band distal end 22a or band proximal end 22b)
  • Sample No. prepared for the peeling test. 1-No. No. 20 was produced by changing the pressing force of the strip 20 on the catheter tube 5 performed in step S005 in FIG. 9 at three levels shown in Table 1. In the production of each sample, in step S005, after adjusting the pressing force to the level shown in Table 1, the pressing force was maintained for about 30 to 50 seconds.
  • the band 20 is cut at the center, thereby from one eccentric balloon catheter 1, a sample whose bonding position is the band-shaped distal end 22a, and a bonding position that is the proximal end of the band-shaped body. Two of the samples, 22b, were made. Furthermore, the end of the cut strip 20 is fixed to the load cell, the catheter tube 5 is fixed to the movable table, and the movable table is moved to pull the strip 20, and the relationship between the tensile distance and the weight of the strip 20 is determined. It was measured. For the peel test, a rheometer (manufactured by Rheotech Co., Ltd.) was used.
  • FIG. 10 shows a sample No. 1 in which the pressing force by the pressing device 60 is level 1 (4.89 N). 1-No. It is a graph showing the result of the peeling test to 6. At this level, in one of the six samples (sample No. 1), the process of stretching the band-like body 20 before rupture was not observed, and poor bonding was confirmed.
  • FIG. 11 shows a sample No. 2 in which the pressing force in the pressing device 60 is level 2 (6.94 N). 7-No. It is a graph showing the result of the peeling test to 12. At this level, no bonding failure was confirmed in any of the samples.
  • the pressing force is within a predetermined range (for example, around the level 2 or the level).
  • a predetermined range for example, around the level 2 or the level.

Abstract

Provided is an apparatus for producing an eccentric balloon catheter in which a balloon swells eccentrically relative to the axial center of a catheter tube, wherein the apparatus for producing an eccentric balloon catheter has: a clamp base that forms a groove part for accommodating the catheter tube, the balloon inserted in and joined to the catheter tube, and an inflation-restricting member for restricting a circumferential-direction part of the balloon from separating from the catheter tube when the balloon is inflated, at least part of the inflation-restricting member being disposed on the catheter tube and the balloon so as to overlap the balloon; a pressing part that is movable relative to the groove part so as to approach and separate from the opening side of the groove part, the pressing part pressing the inflation-restricting member toward the catheter tube; and a detection part for detecting the pressing force exerted by the pressing part.

Description

偏心バルーンカテーテルの製造装置および偏心バルーンカテーテルの製造方法Eccentric balloon catheter manufacturing apparatus and eccentric balloon catheter manufacturing method
　本発明は、バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルの製造装置および偏心バルーンカテーテルの製造方法に関する。 The present invention relates to an eccentric balloon catheter manufacturing apparatus and a method of manufacturing an eccentric balloon catheter in which a balloon is eccentric with respect to the axis of the catheter tube and expands.
　内視鏡を用いた処置では、例えば、胆管内に生じた結石（胆石）を体外に取り出して除去する際などに、バルーンカテーテルが用いられる場合がある。また、そのようなバルーンカテーテルとして、バルーンがカテーテルチューブに対して同心円状に膨らむものの他に、バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルが提案されている。偏心バルーンカテーテルは、同心円状に膨らむバルーンに比べて、結石を効率的に掻き出すことが可能であり、結石を除去する際に好適に用いられる。 In a procedure using an endoscope, for example, a balloon catheter may be used when a calculus (gallstone) generated in the bile duct is removed from the body and removed. Further, as such a balloon catheter, an eccentric balloon catheter in which the balloon is eccentrically inflated with respect to the axis of the catheter tube is proposed in addition to the balloon inflating concentrically with respect to the catheter tube. An eccentric balloon catheter can scrape stones more efficiently than a balloon that bulges concentrically, and is preferably used when removing stones.
　このような偏心バルーンカテーテルとしては、たとえば固定用のテープのようなバルーンの周方向の一部の膨張を規制する部材をカテーテルチューブに固定したものが提案されている。 As such an eccentric balloon catheter, for example, a member in which a member for regulating the expansion of a part of the balloon in the circumferential direction, such as a fixing tape, is fixed to the catheter tube has been proposed.
特開２００６－３４０９１４号公報JP 2006-340914 A 特開２００８－１９４１６６号公報JP 2008-194166 A
　しかしながら、バルーンの膨張を規制する膨張規制部材をバルーンの上から貼りつけるタイプの偏心バルーンカテーテルは、従来の製造方法で製造する限りにおいては、膨張規制部材の接合強度にばらつきが生じやすく、良品率を高めることが難しいという課題を有している。また、完成品における膨張規制部材の接合強度を所定の範囲内にするためには、接着剤のような連結剤の塗布位置や塗布量を厳密に管理する必要があったり、接着部分における接着剤の広がりを厳密にチェックする必要があったりするため、製造作業の難易度が高く、また、効率的な生産が難しいという問題を有している。 However, the eccentric balloon catheter of the type in which an inflation regulating member for regulating the inflation of the balloon is attached from above the balloon is likely to cause variations in the bonding strength of the inflation regulating member as long as it is manufactured by a conventional manufacturing method. It is difficult to increase In addition, in order to keep the bonding strength of the expansion regulating member in the finished product within a predetermined range, it is necessary to strictly control the application position and application amount of a coupling agent such as an adhesive, or the adhesive at the bonded portion. In other words, it is necessary to strictly check the spread of the manufacturing process, so that the difficulty of manufacturing work is high and efficient production is difficult.
　本発明は、このような実状に鑑みてなされ、その目的は、バルーンの膨張を規制する膨張規制部材の接合強度が安定している偏心バルーンカテーテルを製造可能な偏心バルーンカテーテルの製造装置および、そのような偏心バルーンカテーテルの製造方法を提供することである。 The present invention has been made in view of such a situation, and an object of the present invention is to provide an eccentric balloon catheter manufacturing apparatus capable of manufacturing an eccentric balloon catheter in which the bonding strength of an expansion regulating member that regulates inflation of the balloon is stable, and its It is providing the manufacturing method of such an eccentric balloon catheter.
　上記目的を達成するために、本発明に係る偏心バルーンカテーテルの製造装置は、
　バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルの製造装置であって、
　前記カテーテルチューブと、前記カテーテルチューブが挿通および接合した前記バルーンと、少なくとも一部が前記バルーンに重なるように前記カテーテルチューブおよび前記バルーンの上に配置されており前記バルーンが膨張する際において前記バルーンの周方向の一部が前記カテーテルチューブから離間することを規制する膨張規制部材と、を収容する溝部が形成されているクランプ台と、
　前記溝部の開口側から前記溝部に対して近接および離間するように相対移動可能であって、前記膨張規制部材を前記カテーテルチューブに向かって押圧する押圧部と、
　前記押圧部による押圧力を検出する検出部と、を有する。 In order to achieve the above object, an eccentric balloon catheter manufacturing apparatus according to the present invention comprises:
An apparatus for manufacturing an eccentric balloon catheter in which a balloon is eccentric and expands with respect to the axis of a catheter tube,
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon. An expansion restricting member that restricts a part of the circumferential direction from being separated from the catheter tube;
A pressing part that is movable relative to and away from the groove part from the opening side of the groove part, and that presses the expansion regulating member toward the catheter tube;
A detection unit that detects a pressing force by the pressing unit.
　本発明に係る偏心バルーンカテーテルの製造装置は、クランプ台に配置された膨張規制部材をカテーテルチューブに向かって押圧する際の押圧力を検出する検出部を有しているため、製造された偏心バルーンカテーテルにおける膨張規制部材の接合強度を安定させることができる。すなわち、このような製造装置によれば、検出結果に基づき押圧力を適切な範囲に調整することにより、膨張規制部材と接合対象であるバルーンまたはカテーテルとの間に形成された隙間の広さや、膨張規制部材と接合対象との間に形成される連結部の広がりを安定させることが可能であるため、製造された偏心バルーンカテーテルにおける膨張規制部材の接合強度を安定させることができる。また、検出部で押圧力を検出しているため、作業者が熟練者でなくても、膨張規制部材をカテーテルチューブに向かって押圧する際の押圧力を適切に調整することが可能であり、このような偏心バルーンカテーテルの製造装置を用いることにより効率的な製造が可能である。 Since the eccentric balloon catheter manufacturing apparatus according to the present invention has a detection unit that detects a pressing force when the expansion regulating member disposed on the clamp table is pressed toward the catheter tube, the manufactured eccentric balloon is manufactured. The joint strength of the expansion regulating member in the catheter can be stabilized. That is, according to such a manufacturing apparatus, by adjusting the pressing force to an appropriate range based on the detection result, the size of the gap formed between the expansion regulating member and the balloon or catheter to be joined, Since it is possible to stabilize the expansion of the connecting portion formed between the expansion restriction member and the object to be joined, the joint strength of the expansion restriction member in the manufactured eccentric balloon catheter can be stabilized. Moreover, since the pressing force is detected by the detection unit, it is possible to appropriately adjust the pressing force when pressing the expansion regulating member toward the catheter tube even if the operator is not an expert. By using such an eccentric balloon catheter manufacturing apparatus, efficient manufacturing is possible.
　また、例えば、前記押圧部は、前記溝部の延びる方向に沿って所定の間隔を空けて配列されており、前記バルーンより遠位端側において前記膨張規制部材を前記カテーテルチューブに向かって押圧する第１押圧部と、前記バルーンより近位端側において前記膨張規制部材を前記カテーテルチューブに向かって押圧する第２押圧部と、を有していてもよい。 Further, for example, the pressing parts are arranged at a predetermined interval along the extending direction of the groove part, and the pressing part presses the expansion regulating member toward the catheter tube on the distal end side of the balloon. You may have a 1 press part and the 2nd press part which presses the said expansion control member toward the said catheter tube in the proximal end side from the said balloon.
　押圧部が第１押圧部と第２押圧部とを有することにより、バルーンを軸方向に跨ぐ２箇所で、膨張規制部材をカテーテルチューブに対して効率的に接合することができる。すなわち、このような製造装置によれば、膨張規制部材をカテーテルチューブに対して確実に接合することができ、かつ、２箇所同時に押圧できるため作業性も良好である。 When the pressing portion has the first pressing portion and the second pressing portion, the expansion regulating member can be efficiently joined to the catheter tube at two locations straddling the balloon in the axial direction. That is, according to such a manufacturing apparatus, since the expansion regulating member can be reliably bonded to the catheter tube and can be pressed simultaneously at two locations, workability is also good.
　また、例えば、前記検出部は、前記押圧部と前記押圧部に押圧力を伝える押圧力伝達部との間に配置されており、前記押圧部から伝えられる反力に応じて前記押圧部の相対移動方向に変形する変形部と、前記変形部の変形量に対応する前記押圧部の押圧力を表示する表示部と、を有してもよい。 In addition, for example, the detection unit is disposed between the pressing unit and a pressing force transmission unit that transmits a pressing force to the pressing unit, and relative to the pressing unit according to a reaction force transmitted from the pressing unit. You may have a deformation | transformation part which deform | transforms in a moving direction, and a display part which displays the pressing force of the said press part corresponding to the deformation amount of the said deformation | transformation part.
　押圧部の相対移動方向に変形する変形部と、押圧部の押圧力を表示する表示部とを有する製造装置は、製造作業者がより容易に膨張規制部材に対する押圧力を適切な範囲に調整することができるため、製造された偏心バルーンカテーテルにおける膨張規制部材の接合強度を、より安定させることができる。 A manufacturing apparatus having a deforming portion that deforms in the relative movement direction of the pressing portion and a display portion that displays the pressing force of the pressing portion adjusts the pressing force on the expansion regulating member to an appropriate range more easily by the manufacturing operator. Therefore, the joint strength of the expansion regulating member in the manufactured eccentric balloon catheter can be further stabilized.
　また、前記変形部は、圧縮バネを有してもよく、空気圧バネを有してもよく、油圧バネを有してもよい。 In addition, the deforming portion may have a compression spring, a pneumatic spring, or a hydraulic spring.
　変形部は、押圧部から伝えられる反力に応じて変形するものであれば特に限定されないが、例えば圧縮バネ、空気圧バネまたは油圧バネ等を有してもよく、このような変形部により、膨張規制部材に対する押圧力を、より正確に調整することができる。 The deforming part is not particularly limited as long as it deforms according to the reaction force transmitted from the pressing part. For example, the deforming part may include a compression spring, a pneumatic spring, a hydraulic spring, and the like. The pressing force against the regulating member can be adjusted more accurately.
　本発明に係る偏心バルーンカテーテルの製造方法は、バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルの製造方法であって、
　前記カテーテルチューブと、前記カテーテルチューブが挿通および接合した前記バルーンと、少なくとも一部が前記バルーンに重なるように前記カテーテルチューブおよび前記バルーンの上に配置されており前記バルーンが膨張する際において前記バルーンの周方向の一部が前記カテーテルチューブから離間することを規制する膨張規制部材とを、クランプ台に形成された溝部に配置する工程と、
　前記膨張規制部材とカテーテルチューブとの間に接着剤を塗布する工程と、
　前記溝部の開口側から前記クランプ台の前記溝部に対して近接および離間するように相対移動可能な押圧部によって、前記膨張規制部材を前記カテーテルチューブに向かって押圧する工程と、
　前記押圧部による押圧力を検出部が検出する工程と、
　前記検出部による検出結果に基づき前記押圧部による押圧力を調整する工程と、を有する。 The manufacturing method of the eccentric balloon catheter according to the present invention is a manufacturing method of an eccentric balloon catheter in which the balloon is eccentric and inflated with respect to the axis of the catheter tube,
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon. A step of disposing an expansion regulating member that regulates separation of a part of the circumferential direction from the catheter tube in a groove formed in the clamp table;
Applying an adhesive between the expansion regulating member and the catheter tube;
A step of pressing the expansion regulating member toward the catheter tube by a pressing portion that is relatively movable so as to approach and separate from the groove portion of the clamp base from the opening side of the groove portion;
A step of detecting a pressing force by the pressing unit by the detecting unit;
Adjusting the pressing force by the pressing portion based on the detection result by the detecting portion.
　本発明に係る偏心バルーンカテーテルの製造方法によれば、安定した接着強度で接着された膨張規制部材を有する偏心バルーンカテーテルを製造することが可能である。 According to the method for manufacturing an eccentric balloon catheter according to the present invention, it is possible to manufacture an eccentric balloon catheter having an expansion regulating member bonded with a stable adhesive strength.
図１は、本発明の一実施形態に係る製造装置によって製造される偏心バルーンカテーテルの一例を表す概略図である。FIG. 1 is a schematic diagram illustrating an example of an eccentric balloon catheter manufactured by a manufacturing apparatus according to an embodiment of the present invention. 図２は、図１に示す偏心バルーンカテーテルの概略断面図である。FIG. 2 is a schematic cross-sectional view of the eccentric balloon catheter shown in FIG. 図３は、図２に示すIII－III線に沿う偏心バルーンカテーテルの概略断面図である。FIG. 3 is a schematic cross-sectional view of the eccentric balloon catheter taken along line III-III shown in FIG. 図４は、本発明の一実施形態に係る偏心バルーンカテーテルの製造装置を表す概略斜視図である。FIG. 4 is a schematic perspective view showing an eccentric balloon catheter manufacturing apparatus according to an embodiment of the present invention. 図５は、図４に示す製造装置の部分拡大図である。FIG. 5 is a partially enlarged view of the manufacturing apparatus shown in FIG. 図６は、図４に示す製造装置に含まれるクランプ台の斜視図である。6 is a perspective view of a clamp base included in the manufacturing apparatus shown in FIG. 図７は、図４に示す製造装置におけるクランプ台に設置されたカテーテルチューブ、バルーン及び膨張規制部材を表す概略平面図である。7 is a schematic plan view showing a catheter tube, a balloon, and an expansion regulating member installed on a clamp base in the manufacturing apparatus shown in FIG. 図８は、図４に示す製造装置による偏心バルーンカテーテルの製造方法を表す概念図である。FIG. 8 is a conceptual diagram showing a manufacturing method of the eccentric balloon catheter by the manufacturing apparatus shown in FIG. 図９は、図４に示す製造装置による偏心バルーンカテーテルの製造工程の一例を表すフローチャートである。FIG. 9 is a flowchart showing an example of a manufacturing process of the eccentric balloon catheter by the manufacturing apparatus shown in FIG. 図１０は、実施例における引き剥がし試験の結果（水準１）を表すグラフである。FIG. 10 is a graph showing the result (level 1) of the peeling test in the example. 図１１は、実施例における引き剥がし試験の結果（水準２）を表すグラフである。FIG. 11 is a graph showing the result (level 2) of the peeling test in the example. 図１２は、実施例における引き剥がし試験の結果（水準３）を表すグラフである。FIG. 12 is a graph showing the result (level 3) of the peeling test in the example.
　以下、本発明を、図面に示す実施形態に基づき説明する。 Hereinafter, the present invention will be described based on embodiments shown in the drawings.
　図１は、本発明の一実施形態に係る製造装置によって製造される偏心バルーンカテーテル１の一例を表す概略図である。偏心バルーンカテーテル１は、カテーテルチューブ５と、バルーン２と、膨張規制部材としての帯状体２０とを有している。図１に示すように、偏心バルーンカテーテル１は、バルーン２がカテーテルチューブ５の軸心に対して偏芯して膨らむ。 FIG. 1 is a schematic view showing an example of an eccentric balloon catheter 1 manufactured by a manufacturing apparatus according to an embodiment of the present invention. The eccentric balloon catheter 1 has a catheter tube 5, a balloon 2, and a belt-like body 20 as an expansion regulating member. As shown in FIG. 1, in the eccentric balloon catheter 1, the balloon 2 swells eccentrically with respect to the axis of the catheter tube 5.
　カテーテルチューブ５は、可撓性材料によって形成されたチューブであって、体内に挿入される側の端部であるチューブ遠位端部７と、その他端側に位置する近位端部（図示省略）とを有している。カテーテルチューブ５の外径ｄ１は、例えば１～３ｍｍ程度であり、全長は５００～２５００ｍｍ程度とすることができるが特に限定されず、カテーテルチューブ５のサイズは、偏心バルーンカテーテル１の用途等に応じて適宜変更される。また、カテーテルチューブ５の材料は、可撓性を有する材料であれば特に限定されないが、高分子材料であることが好ましく、なかでも、ポリアミド樹脂あるいはポリアミド系エラストマーであることが特に好ましい。 The catheter tube 5 is a tube made of a flexible material, and is a tube distal end portion 7 which is an end portion to be inserted into the body and a proximal end portion (not shown) located on the other end side. ). The outer diameter d1 of the catheter tube 5 is, for example, about 1 to 3 mm, and the total length can be about 500 to 2500 mm, but is not particularly limited. The size of the catheter tube 5 depends on the use of the eccentric balloon catheter 1 and the like. As appropriate. The material of the catheter tube 5 is not particularly limited as long as it is a flexible material, but is preferably a polymer material, and particularly preferably a polyamide resin or a polyamide-based elastomer.
　カテーテルチューブ５の内部には、図２に示すように、バルーンルーメン８と、造影剤ルーメン９と、ガイドワイヤルーメン１０とが形成されている。バルーンルーメン８は、バルーン２を膨張させるために用いる空気等の流体をバルーン２の内部空間２４に送るための流路となるルーメンである。このバルーンルーメン８は、カテーテルチューブ５の近位端から、カテーテルチューブ５の遠位端部であるチューブ遠位端部７の途中まで延びており、バルーン２の内部空間２４に開口するように設けられた流体導出口１１と導通している。 As shown in FIG. 2, a balloon lumen 8, a contrast medium lumen 9, and a guide wire lumen 10 are formed inside the catheter tube 5. The balloon lumen 8 is a lumen serving as a flow path for sending a fluid such as air used to inflate the balloon 2 to the internal space 24 of the balloon 2. The balloon lumen 8 extends from the proximal end of the catheter tube 5 to the middle of the tube distal end 7 which is the distal end of the catheter tube 5, and is provided so as to open into the internal space 24 of the balloon 2. Is connected to the fluid outlet 11.
　造影剤ルーメン９は、結石の位置を確認する等の目的で、体内のＸ線造影を行う場合に、造影剤の流路として用いるルーメンである。この造影剤ルーメン９は、カテーテルチューブ５の近位端から、カテーテルチューブ５のチューブ遠位端部７の噴出口１２まで貫通している。噴出口１２は、バルーン２より近位端側に位置するように設けられた開口である。なお噴出口は、バルーン２より遠位端側に位置するように設けられた開口であってもよい。 The contrast medium lumen 9 is a lumen used as a contrast medium channel when performing X-ray contrast in the body for the purpose of confirming the position of the calculus. The contrast medium lumen 9 penetrates from the proximal end of the catheter tube 5 to the spout 12 at the distal end portion 7 of the catheter tube 5. The spout 12 is an opening provided so as to be positioned closer to the proximal end than the balloon 2. The spout may be an opening provided so as to be located on the distal end side of the balloon 2.
　ガイドワイヤルーメン１０は、偏心バルーンカテーテル１をガイドワイヤに沿わせて体内に挿入する際に、ガイドワイヤを挿通させるルーメンであり、カテーテルチューブ５の近位端から遠位端開口１０ａまで貫通している。なお、カテーテルチューブ５において、造影剤ルーメンおよびガイドワイヤルーメン１０は必ずしも設ける必要はなく、また、上記した機能以外の機能を有する他のルーメンが形成されていてもよい。 The guide wire lumen 10 is a lumen through which the guide wire is inserted when the eccentric balloon catheter 1 is inserted into the body along the guide wire, and penetrates from the proximal end of the catheter tube 5 to the distal end opening 10a. Yes. In the catheter tube 5, the contrast medium lumen and the guide wire lumen 10 are not necessarily provided, and other lumens having functions other than the functions described above may be formed.
　バルーンルーメン８、造影剤ルーメン９およびガイドワイヤルーメン１０の断面形状は、いずれも限定されず、それぞれをカテーテルチューブ５内に効率的に配置できる形状とすればよい。但し、ガイドワイヤルーメン１０については、断面形状が円形であることが好ましい。また、バルーンルーメン８の断面積は例えば０．０３～０．３ｍｍ２、造影剤ルーメン９の断面積は例えば０．０８～０．８ｍｍ２、ガイドワイヤルーメン１０の断面積は例えば０．５～１．０ｍｍ２とすることができるが、各ルーメンの断面積は特に限定されず、カテーテルチューブの外径等に応じて適宜変更される。 The cross-sectional shapes of the balloon lumen 8, the contrast medium lumen 9, and the guide wire lumen 10 are not limited, and may be shapes that can be efficiently arranged in the catheter tube 5. However, the guide wire lumen 10 preferably has a circular cross-sectional shape. The sectional area of the balloon lumen 8 is, for example, 0.03 to 0.3 mm 2, the sectional area of the contrast medium lumen 9 is, for example, 0.08 to 0.8 mm 2, and the sectional area of the guide wire lumen 10 is, for example, 0.5 to 1. Although it can be 0 mm 2, the cross-sectional area of each lumen is not particularly limited, and can be appropriately changed according to the outer diameter of the catheter tube and the like.
　偏心バルーンカテーテル１のバルーン２は、カテーテルチューブ５のチューブ遠位端部７付近に、カテーテルチューブ５に形成された流体導出口１１を覆うように取り付けられている。このバルーン２は、伸縮性材料により形成されていて、カテーテルチューブ５のバルーンルーメン８を介して、内部空間２４に流体が導入されることにより膨張されるようになっている。この膨張したバルーン２によって、図２に示すような結石５０を掻き出したり、押し出したりして、体内の結石の除去を行うことができる。 The balloon 2 of the eccentric balloon catheter 1 is attached in the vicinity of the distal end portion 7 of the catheter tube 5 so as to cover the fluid outlet 11 formed in the catheter tube 5. The balloon 2 is formed of a stretchable material, and is inflated by introducing a fluid into the internal space 24 via the balloon lumen 8 of the catheter tube 5. With the inflated balloon 2, a calculus 50 as shown in FIG. 2 can be scraped or pushed out to remove the calculus in the body.
　バルーン２を形成する伸縮性材料としては、１００％モジュラス（ＪＩＳ　Ｋ　６２５１に準拠して測定した値）が、０．１～１０Ｍｐａであるものが好ましく、１～５Ｍｐａであるものが特に好ましい。１００％モジュラスが小さすぎると、バルーン２の強度が不足するおそれがあり、大きすぎると、バルーン２を十分な大きさに膨張できなくなるおそれがある。また、バルーン２を形成するために好適な伸縮性材料の具体例としては、天然ゴム、シリコーンゴム、ポリウレタンエラストマー等が挙げられる。 The stretchable material forming the balloon 2 is preferably a material having a 100% modulus (measured in accordance with JIS K 6251) of 0.1 to 10 Mpa, particularly preferably 1 to 5 Mpa. If the 100% modulus is too small, the strength of the balloon 2 may be insufficient. If it is too large, the balloon 2 may not be expanded to a sufficient size. Specific examples of the stretchable material suitable for forming the balloon 2 include natural rubber, silicone rubber, polyurethane elastomer, and the like.
　図１～図３に示すように、バルーン２は、全体として筒状であってカテーテルチューブ５が挿通しており、その両端部にカテーテルチューブ５の外周面と接合される接合部４ａ、４ｂが形成されている。バルーン２の膨張部３の両端側に位置する接合部４ａ、４ｂの形状は、カテーテルチューブ５の外周面に接合可能な形状であれば特に限定されないが、円筒形であることが好ましい。 As shown in FIG. 1 to FIG. 3, the balloon 2 has a tubular shape as a whole, and the catheter tube 5 is inserted therethrough, and joint portions 4a and 4b joined to the outer peripheral surface of the catheter tube 5 at both ends thereof. Is formed. The shape of the joint portions 4a and 4b located at both ends of the inflatable portion 3 of the balloon 2 is not particularly limited as long as it can be joined to the outer peripheral surface of the catheter tube 5, but is preferably a cylindrical shape.
　バルーン２の接合部４ａ、４ｂが円筒形である場合、その内径はカテーテルチューブ５の外径とほぼ等しいことが好ましく、その長さは、０．５～５ｍｍであることが好ましい。また、バルーン２の接合部４ａ、４ｂの肉厚は、特に限定されず、例えば、膨張部３と実質的に等しくすれば良い。なお、バルーン２の接合部４ａ、４ｂとカテーテルチューブ５の外周面とを接合する手法は、特に限定されず、例えば、接着剤による接着、熱融着、溶剤による溶着、超音波溶着などを挙げることができる。 When the joints 4a and 4b of the balloon 2 are cylindrical, the inner diameter is preferably substantially equal to the outer diameter of the catheter tube 5, and the length is preferably 0.5 to 5 mm. Further, the thickness of the joint portions 4a and 4b of the balloon 2 is not particularly limited, and may be substantially equal to the inflatable portion 3, for example. In addition, the method of joining the joining parts 4a and 4b of the balloon 2 and the outer peripheral surface of the catheter tube 5 is not particularly limited, and examples thereof include adhesion with an adhesive, thermal fusion, welding with a solvent, and ultrasonic welding. be able to.
　バルーン２において、接合部４ａ、４ｂの間には、内部空間２４に流体が導入されることにより膨張する膨張部３が形成されている。図１～図３では、膨張されたバルーン２が示されている。バルーン２の膨張部３は、膨らんだ状態での最大外径が、萎んだ状態での最小外径の１１０～２００％であることが好ましい。この比率が小さすぎると、バルーン２が十分な大きさに膨張しないおそれがあり、大きすぎると、偏心バルーンカテーテル１を体内に挿入する際にバルーン２が邪魔になるおそれがある。また、バルーン２における膨張部３の長さ（カテーテルチューブ５の軸方向に沿った長さ）は、５～２０ｍｍが好ましく、肉厚は、０．１０～０．５０ｍｍであることが好ましい。バルーン２の肉厚は、周方向に沿って均一であることが好ましい。 In the balloon 2, an inflatable portion 3 that is inflated by introducing a fluid into the internal space 24 is formed between the joint portions 4a and 4b. 1-3, an inflated balloon 2 is shown. The inflated portion 3 of the balloon 2 preferably has a maximum outer diameter in the inflated state of 110 to 200% of the minimum outer diameter in the deflated state. If this ratio is too small, the balloon 2 may not expand to a sufficient size, and if it is too large, the balloon 2 may become an obstacle when the eccentric balloon catheter 1 is inserted into the body. Further, the length of the inflatable portion 3 in the balloon 2 (the length along the axial direction of the catheter tube 5) is preferably 5 to 20 mm, and the wall thickness is preferably 0.10 to 0.50 mm. The wall thickness of the balloon 2 is preferably uniform along the circumferential direction.
　上記したような形状を有するバルーン２を製造する方法は特に限定されず、伸縮性材料の製膜方法として公知の方法を用いればよいが、ディッピング成形法を用いることが好ましい。ディッピング成形法では、伸縮性材料と必要に応じて各種添加剤を溶剤に溶解して溶液あるいは懸濁液とし、この溶液（懸濁液）に所望するバルーンの形状と略等しい外形を有する型を浸漬させて型の表面に溶液（懸濁液）を塗布し、溶剤を蒸発させて型の表面に被膜を形成させる。この浸漬と乾燥を繰り返すことにより所望の肉厚を有するバルーンを製膜することができる。なお、伸縮性材料の種類により、必要に応じて、製膜後、架橋を行う。 The method for producing the balloon 2 having the shape as described above is not particularly limited, and a known method may be used as a method for forming the stretchable material, but it is preferable to use a dipping method. In the dipping molding method, a stretchable material and various additives as necessary are dissolved in a solvent to form a solution or suspension, and a mold having an outer shape substantially equal to the desired balloon shape is formed in this solution (suspension). It is immersed and a solution (suspension) is applied to the surface of the mold, and the solvent is evaporated to form a film on the surface of the mold. By repeating this immersion and drying, a balloon having a desired thickness can be formed. Depending on the type of stretchable material, crosslinking is performed after film formation, if necessary.
　図１に示すように、偏心バルーンカテーテル１は、膨張規制部材としての帯状体２０を有している。膨張規制部材としての帯状体２０は、少なくとも一部がバルーン２に重なるようにカテーテルチューブ５およびバルーン２の上に配置されており、バルーン２が膨張する際においてバルーン２の周方向の一部がカテーテルチューブ５から離間することを規制する。帯状体２０は、カテーテルチューブ５の軸方向に沿って、バルーン２を跨ぐように伸びており、帯状体２０の軸方向長さは、バルーン２の軸方向長さよりも長い。帯状体２０の近位端部である帯状体近位端部２２ｂは、バルーン２より近位端側でカテーテルチューブ５の外周面に固定してあり、帯状体２０の遠位端部である帯状体遠位端部２２ａは、バルーン２より遠位端側でカテーテルチューブ５の外周面に固定してある。 As shown in FIG. 1, the eccentric balloon catheter 1 has a belt-like body 20 as an expansion regulating member. The belt-like body 20 as the expansion regulating member is disposed on the catheter tube 5 and the balloon 2 so that at least a part thereof overlaps the balloon 2, and when the balloon 2 is inflated, a part of the balloon 2 in the circumferential direction is disposed. The separation from the catheter tube 5 is restricted. The belt-like body 20 extends along the axial direction of the catheter tube 5 so as to straddle the balloon 2, and the axial length of the belt-like body 20 is longer than the axial length of the balloon 2. The band-like body proximal end portion 22 b that is the proximal end portion of the band-like body 20 is fixed to the outer peripheral surface of the catheter tube 5 on the proximal end side from the balloon 2, and is a band-like shape that is the distal end portion of the band-like body 20. The body distal end 22 a is fixed to the outer peripheral surface of the catheter tube 5 on the distal end side of the balloon 2.
　帯状体２０の材質としては、特に限定されず、例えばカテーテルチューブ５を構成する樹脂と同様な樹脂で構成される。ただし、バルーン２が膨張する際に、帯状体２０がバルーン２の膨張を規制し、膨張したバルーン２の中心がカテーテルチューブ５の中心に比べて、帯状体２０から離間できるように、帯状体２０は、バルーン２より伸縮性の小さい材料で構成されることが好ましい。また、帯状体近位端部２２ｂおよび帯状体遠位端部２２ａと、その接合対象であるカテーテルチューブ５との接合方法は、特に限定されず、接着、熱融着、高周波融着などを挙げることができる。 The material of the belt-like body 20 is not particularly limited, and for example, it is made of the same resin as that constituting the catheter tube 5. However, when the balloon 2 is inflated, the band-shaped body 20 regulates the expansion of the balloon 2, and the center of the inflated balloon 2 can be separated from the band-shaped body 20 compared to the center of the catheter tube 5. Is preferably made of a material that is less stretchable than the balloon 2. Moreover, the joining method of the band-like body proximal end 22b and the band-like body distal end 22a and the catheter tube 5 to be joined is not particularly limited, and examples thereof include adhesion, heat fusion, and high-frequency fusion. be able to.
　帯状体２０の幅は、カテーテルチューブ５の外周における円周方向長さの１／２以下の幅であり、好ましくは１／３～１／５の幅である。この幅が小さすぎると、バルーン２の上から当該バルーン２の周方向の一部がカテーテルチューブ５から離間することを規制する機能が小さくなり、幅が大きすぎると、バルーン２を十分に膨らませることが困難になる。 The width of the belt-like body 20 is a width of 1/2 or less of the circumferential length on the outer periphery of the catheter tube 5, and preferably a width of 1/3 to 1/5. If the width is too small, the function of restricting the circumferential portion of the balloon 2 from separating from the catheter tube 5 from above the balloon 2 becomes small. If the width is too large, the balloon 2 is sufficiently inflated. It becomes difficult.
　偏心バルーンカテーテル１では、バルーン２が膨張する際においてバルーン２の周方向の一部がカテーテルチューブ５から離間することを規制する帯状体２０がカテーテルチューブ５に接合されているため、図３に示すように、バルーン２の膨張部３がカテーテルチューブ５の軸心に対して偏心して膨張する。カテーテルチューブ５の軸心に対する膨張部３の膨張中心の偏心量ｈ１は、膨張部３の膨張半径Ｒに対して、好ましくは５０～１００％、さらに好ましくは７５～１００％である。なお、バルーン２は、その横断面において、完全に円形に膨張する必要はなく、楕円形、その他の形状に膨張しても良い。 In the eccentric balloon catheter 1, a band-like body 20 that restricts the circumferential portion of the balloon 2 from being separated from the catheter tube 5 when the balloon 2 is inflated is joined to the catheter tube 5, and is shown in FIG. 3. As described above, the expansion portion 3 of the balloon 2 expands eccentrically with respect to the axis of the catheter tube 5. The eccentric amount h1 of the expansion center of the expansion part 3 with respect to the axis of the catheter tube 5 is preferably 50 to 100%, more preferably 75 to 100% with respect to the expansion radius R of the expansion part 3. The balloon 2 does not need to be completely inflated in the cross section, and may be inflated into an elliptical shape or other shapes.
　図１および図２に示すように、偏心バルーンカテーテル１では、カテーテルチューブ５における外周面の２箇所に、造影リング２６ａ、２６ｂが設けられている。造影リング２６ａは、バルーン２の内部空間２４に配置されており、造影リング２６ｂは、バルーン２の外部であって、バルーン２における近位端側の接合部４ｂに近接する位置に配置されているが、造影リング２６ａ、２６ｂの配置、形状および数は特に限定されない。造影リング２６ａ、２６ｂは、例えばＸ線不透過材料である金、プラチナ、プラチナイリジウム合金等の金属や、Ｘ線造影物質の粉末を含有する樹脂組成物を用いて作製される。 1 and 2, in the eccentric balloon catheter 1, contrast rings 26a and 26b are provided at two locations on the outer peripheral surface of the catheter tube 5. As shown in FIG. The contrast ring 26 a is disposed in the internal space 24 of the balloon 2, and the contrast ring 26 b is disposed outside the balloon 2 and in a position close to the joint portion 4 b on the proximal end side of the balloon 2. However, the arrangement, shape and number of the contrast rings 26a and 26b are not particularly limited. The contrast rings 26a and 26b are manufactured using, for example, a metal composition such as gold, platinum, or platinum iridium alloy, which is an X-ray opaque material, or a resin composition containing powder of an X-ray contrast material.
　図４は、偏心バルーンカテーテル１の製造装置であり、クランプ台６１に配置された対象物である帯状体２０をカテーテルチューブ５に対して押圧する押圧装置６０を表す概略図である。押圧装置６０は、台座６４と、台座６４から上方に延びる支柱６６と、支柱から水平方向に延びており支柱６６に片持ち支持される梁６７とを有している。また、押圧装置６０は、梁６７の下方において台座６４の上に設置されるクランプ台６１と、梁６７に対して相対移動可能に連結されている押圧力伝達部材６８と、押圧力伝達部材６８に対して変形部７１を間に挟んで接続されており、クランプ台６１の溝部６２に対して近接および離間するように相対移動可能な押圧部６９とを有している。さらに、押圧装置６０は、押圧力伝達部材６８および押圧部６９を上下方向に移動させるためのレバー６５と、押圧部６９による押圧力を検出する検出部７０とを有している。 FIG. 4 is a schematic view showing a pressing device 60 which is a manufacturing apparatus of the eccentric balloon catheter 1 and presses the band-like body 20 which is an object placed on the clamp table 61 against the catheter tube 5. The pressing device 60 includes a pedestal 64, a support column 66 that extends upward from the pedestal 64, and a beam 67 that extends horizontally from the support column and is cantilevered by the support column 66. The pressing device 60 includes a clamp base 61 installed on a base 64 below the beam 67, a pressing force transmission member 68 connected to the beam 67 so as to be relatively movable, and a pressing force transmission member 68. And a pressing portion 69 that is relatively movable so as to approach and separate from the groove portion 62 of the clamp base 61. Further, the pressing device 60 includes a lever 65 for moving the pressing force transmission member 68 and the pressing portion 69 in the vertical direction, and a detection unit 70 for detecting the pressing force by the pressing portion 69.
　押圧装置６０は、レバー６５を手前側へ回転させると押圧力伝達部材６８および押圧部６９がクランプ台６１へ向かって下降し、レバー６５を奥側へ回転させると押圧力伝達部材６８および押圧部６９が上昇してクランプ台６１から離間するようになっている。クランプ台６１の拡大図である図６に示すように、クランプ台６１には上方に開口する溝部６２が形成されている。 In the pressing device 60, when the lever 65 is rotated to the front side, the pressing force transmission member 68 and the pressing portion 69 descend toward the clamp base 61, and when the lever 65 is rotated to the back side, the pressing force transmission member 68 and the pressing portion. 69 rises and is separated from the clamp base 61. As shown in FIG. 6, which is an enlarged view of the clamp table 61, a groove portion 62 that opens upward is formed in the clamp table 61.
　図７は、クランプ台６１およびクランプ台６１の溝部６２に収容されたカテーテルチューブ５等を上方から見た概念図である。クランプ台６１の溝部６２には、カテーテルチューブ５におけるチューブ遠位端部７の近傍と、カテーテルチューブ５に接合されたバルーン２と、カテーテルチューブ５に対して接合される前の帯状体２０が収容されている。帯状体２０は、カテーテルチューブ５の軸方向に沿ってバルーン２を跨ぐように、カテーテルチューブ５およびバルーン２の上方に配置されている。 FIG. 7 is a conceptual view of the clamp base 61 and the catheter tube 5 accommodated in the groove 62 of the clamp base 61 as viewed from above. The groove 62 of the clamp base 61 accommodates the vicinity of the tube distal end portion 7 of the catheter tube 5, the balloon 2 joined to the catheter tube 5, and the band-like body 20 before joining to the catheter tube 5. Has been. The belt-like body 20 is disposed above the catheter tube 5 and the balloon 2 so as to straddle the balloon 2 along the axial direction of the catheter tube 5.
　帯状体２０の近位端部である帯状体近位端部２２ｂとカテーテルチューブ５の外周面の間、および帯状体２０の遠位端部である帯状体遠位端部２２ａとカテーテルチューブ５の外周面の間には、帯状体２０をカテーテルチューブ５に接合するための接着剤が塗布される。図６に示すように、クランプ台６１には、後述する押圧装置６０における押圧動作中において、カテーテルチューブ５、バルーン２および帯状体２０が位置ずれを起こしたり、溝部６２から逸脱したりすることを防止するための固定板６３が設けられている。 Between the proximal end 22b of the strip 20 which is the proximal end of the strip 20 and the outer peripheral surface of the catheter tube 5 and between the distal end 22a of the strip 20 which is the distal end of the strip 20 and the catheter tube 5 An adhesive for joining the strip 20 to the catheter tube 5 is applied between the outer peripheral surfaces. As shown in FIG. 6, during the pressing operation of the pressing device 60, which will be described later, the catheter tube 5, the balloon 2, and the belt-shaped body 20 may be displaced or deviate from the groove 62. A fixing plate 63 is provided to prevent this.
　押圧装置６０の部分拡大図である図５に示すように、押圧部６９は、押圧部６９に対して押圧力を伝える押圧力伝達部材６８の下方先端に、押圧力伝達部材６８との間に変形部７１を挟んで接続されている。変形部７１は、押圧部６９の相対移動方向である上下方向に弾性変形する圧縮バネで構成されており、押圧部６９を下方へ付勢している。押圧部６９は、操作者が図１に示すレバー６５を操作することにより、クランプ台６１における溝部６２に対して、その開口側から近接および離間するよう相対移動する。 As shown in FIG. 5, which is a partially enlarged view of the pressing device 60, the pressing portion 69 is provided between the pressing force transmitting member 68 at the lower end of the pressing force transmitting member 68 that transmits the pressing force to the pressing portion 69. They are connected with the deformation portion 71 interposed therebetween. The deforming part 71 is composed of a compression spring that is elastically deformed in the vertical direction, which is the relative movement direction of the pressing part 69, and biases the pressing part 69 downward. When the operator operates the lever 65 shown in FIG. 1, the pressing portion 69 moves relative to the groove portion 62 in the clamp base 61 so as to approach and separate from the opening side.
　また、押圧部６９は、押圧力伝達部材６８に対して上下方向に相対移動可能であり、押圧部６８が押圧対象である帯状体２０等から反力を受けた場合、変形部７１が収縮することにより、押圧部６９が押圧力伝達部材６８に対して上方に相対移動する。 Further, the pressing portion 69 can move relative to the pressing force transmitting member 68 in the vertical direction, and when the pressing portion 68 receives a reaction force from the belt-like body 20 or the like to be pressed, the deforming portion 71 contracts. As a result, the pressing portion 69 moves upward relative to the pressing force transmission member 68.
　押圧部６９は、クランプ台６１における溝部６２の延びる方向に沿って所定の間隔を空けて配列されている第１押圧部６９ａと第２押圧部６９ｂとを有している。遠位端側に配置される第１押圧部６９ａは、図７に示す帯状体遠位端部２２ａをカテーテルチューブ５に向かって押圧し、近位端側に配置される第２押圧部６９ｂは、図７に示す帯状体近位端部２２ｂをカテーテルチューブ５に向かって押圧する。 The pressing part 69 has a first pressing part 69a and a second pressing part 69b arranged at a predetermined interval along the extending direction of the groove part 62 in the clamp base 61. The first pressing portion 69a disposed on the distal end side presses the band-shaped body distal end portion 22a shown in FIG. 7 toward the catheter tube 5, and the second pressing portion 69b disposed on the proximal end side is The band-like body proximal end portion 22 b shown in FIG. 7 is pressed toward the catheter tube 5.
　図５に示すように、押圧装置６０は、押圧部６９による押圧力を検出する検出部７０を有している。検出部７０は、押圧部６９と押圧力伝達部材６８との間に配置されており、押圧部６９から伝えられる反力に応じて変形する変形部７１と、変形部７１の変形量に対応する押圧力を表示する表示部としての目盛り７２とを有している。 As shown in FIG. 5, the pressing device 60 has a detection unit 70 that detects the pressing force by the pressing unit 69. The detection unit 70 is disposed between the pressing unit 69 and the pressing force transmission member 68, and corresponds to the deformation unit 71 that deforms according to the reaction force transmitted from the pressing unit 69, and the deformation amount of the deformation unit 71. And a scale 72 as a display unit for displaying the pressing force.
　検出部７０の目盛り７２は押圧部６９の表面に形成されており、変形部７１の変形量に応じて相対移動する押圧力伝達部材６８の下端６８ａと目盛り７２との位置関係により、押圧部６９による押圧力が表示される。 The scale 72 of the detection unit 70 is formed on the surface of the pressing unit 69, and the pressing unit 69 depends on the positional relationship between the lower end 68 a of the pressing force transmitting member 68 that moves relative to the deformation amount of the deformation unit 71 and the scale 72. The pressing force by is displayed.
　押圧装置６０に含まれる各部材の材質は特に限定されないが、台座６４、支柱６６、押圧力伝達部材６８及び押圧部６９等は、耐久性および安定性等の観点から鉄やステンレスのような金属材料で作製されることが好ましい。また、変形部７１を構成する圧縮バネは、たとえば高炭素鋼やステンレス鋼線のような硬質金属により作製されるが、特に限定されない。また、クランプ台６１についても、金属や樹脂等の材料を用いて作製することができ、材質は特に限定されないが、たとえばＰＴＦＥで作製されることが、余剰の接着剤がクランプ台６１に付着した場合にも、これを容易に除去可能であるため好ましい。 The material of each member included in the pressing device 60 is not particularly limited, but the pedestal 64, the support column 66, the pressing force transmission member 68, the pressing portion 69, and the like are made of metal such as iron or stainless steel from the viewpoint of durability and stability. Preferably it is made of a material. Moreover, the compression spring which comprises the deformation | transformation part 71 is produced, for example by hard metals, such as high carbon steel and a stainless steel wire, but it is not specifically limited. Also, the clamp table 61 can be manufactured using a material such as metal or resin, and the material is not particularly limited. For example, it is manufactured by PTFE. Also in this case, it is preferable because it can be easily removed.
　図９は、図４に示す押圧装置６０を用いた偏心バルーンカテーテル１の製造工程の一例を表すフローチャートである。以下、図９等を用いて偏心バルーンカテーテル１の製造工程を説明する。 FIG. 9 is a flowchart showing an example of a manufacturing process of the eccentric balloon catheter 1 using the pressing device 60 shown in FIG. Hereinafter, the manufacturing process of the eccentric balloon catheter 1 will be described with reference to FIG.
　図９に示すステップＳ００１では、図２に示すカテーテルチューブ５のチューブ遠位端部７近傍にバルーン２を接合する。具体的には、バルーン２の接合部４ａ、４ｂを、カテーテルチューブ５の外周面に対して接着剤等を用いて、または熱融着により固定する。なお、偏心バルーンカテーテル１が造影リング２６ａ、２６ｂを有する場合は、ステップＳ００１の前後において、造影リング２６ａ、２６ｂをカテーテルチューブ５の所定位置に、接着剤等により固定する。 In step S001 shown in FIG. 9, the balloon 2 is joined in the vicinity of the distal end portion 7 of the catheter tube 5 shown in FIG. Specifically, the joint portions 4a and 4b of the balloon 2 are fixed to the outer peripheral surface of the catheter tube 5 using an adhesive or the like, or by heat fusion. When the eccentric balloon catheter 1 has the contrast rings 26a and 26b, the contrast rings 26a and 26b are fixed to predetermined positions of the catheter tube 5 with an adhesive or the like before and after step S001.
　図９に示すステップＳ００２では、ステップＳ００１でバルーン２を接合したカテーテルチューブ５と、帯状体２０とを、クランプ台６１の溝部６２にセットする。この際、まずクランプ台６１の溝部６２に、バルーン２を接合したカテーテルチューブ５を配置し、次に、図７に示すようにバルーン２の上に重ねて帯状体２０を配置する。この際、帯状体２０の両端部である帯状体遠位端部２２ａおよび帯状体近位端部２２ｂが、バルーン２の遠位端側および近位端側にはみ出すように、帯状体２０がカテーテルチューブ５に対して配置される。溝部６２に配置されたカテーテルチューブ５、バルーン２および帯状体２０は、図６に示す固定板６３を用いて溝部６２に固定される。 In step S002 shown in FIG. 9, the catheter tube 5 to which the balloon 2 is joined in step S001 and the belt-like body 20 are set in the groove portion 62 of the clamp base 61. At this time, first, the catheter tube 5 to which the balloon 2 is joined is disposed in the groove portion 62 of the clamp base 61, and then the belt-like body 20 is disposed on the balloon 2 as shown in FIG. At this time, the band 20 is a catheter so that the band distal end 22a and the band proximal end 22b, which are both ends of the band 20, protrude from the distal end side and the proximal end side of the balloon 2. It is arranged with respect to the tube 5. The catheter tube 5, the balloon 2, and the strip 20 disposed in the groove 62 are fixed to the groove 62 using a fixing plate 63 shown in FIG. 6.
　図９に示すステップＳ００３では、帯状体２０をカテーテルチューブ５に接合するための接着剤を塗布する。具体的には、帯状体２０の帯状体遠位端部２２ａを持ち上げ、帯状体遠位端部２２ａの下方に位置するカテーテルチューブ５の外周面に接着剤を塗布した後、帯状体遠位端部２２ａを塗布した接着剤の上に重ねる。帯状体近位端部２２ｂについても、帯状体遠位端部２２ａと同様に行う。ただし、図７に示すように、帯状体近位端部２２ｂの一部は、造影リング２６ｂの上に位置しているため、帯状体近位端部２２ｂを固定する接着剤の一部は、造影リング２６ｂの上にも塗布される。 In step S003 shown in FIG. 9, an adhesive for joining the strip 20 to the catheter tube 5 is applied. Specifically, after the band-like body distal end 22a of the band-like body 20 is lifted and an adhesive is applied to the outer peripheral surface of the catheter tube 5 positioned below the band-like body distal end 22a, the band-like body distal end The part 22a is overlaid on the applied adhesive. The strip-like body proximal end portion 22b is also performed in the same manner as the strip-like body distal end portion 22a. However, as shown in FIG. 7, a part of the band proximal end 22b is located on the contrast ring 26b, and therefore a part of the adhesive for fixing the band proximal end 22b is It is also applied on the contrast ring 26b.
　図８は、図７における帯状体遠位端部２２ａおよび帯状体近位端部２２ｂの周辺を表す断面図である。帯状体近位端部２２ｂをカテーテルチューブ５に固定する接着剤７８ｂは、バルーン２に対して所定の間隔を空けて配置されており、バルーン２に接触しないようにすることが好ましい。バルーン２の膨張を必要以上に規制することを防止し、また、バルーン２の膨張に伴い接着部分が剥離することを防止するためである。帯状体遠位端部２２ａをカテーテルチューブ５に固定する接着剤７８ａについても同様である。 FIG. 8 is a cross-sectional view showing the periphery of the strip-like body distal end portion 22a and the strip-like body proximal end portion 22b in FIG. The adhesive 78b for fixing the band-like body proximal end portion 22b to the catheter tube 5 is preferably disposed at a predetermined interval with respect to the balloon 2 so as not to contact the balloon 2. This is to prevent the expansion of the balloon 2 from being unnecessarily restricted, and to prevent the bonded portion from peeling off as the balloon 2 expands. The same applies to the adhesive 78a for fixing the band-like body distal end portion 22a to the catheter tube 5.
　図９に示すステップＳ００４では、クランプ台６１の溝部６２にセットされた帯状体２０をカテーテルチューブ５に向かって押圧する。具体的には、図４に示すように、ステップＳ００３で接着剤を塗布したカテーテルチューブ５がセットされたクランプ台６１を、押圧装置６０における押圧部６９の下方に固定する。次に、押圧装置６０の操作者は、図４に示すレバー６５を手前側に回転させることにより、押圧力伝達部材６８および押圧力伝達部材６８の下端に接続されている押圧部６９を下方に移動させる。これに伴い、図５に示す押圧部６９の第１押圧部６９ａおよび第２押圧部６９ｂが、溝部６２に対して溝部６２の開口側から近づいていく。さらに、図８に示すように、第１押圧部６９ａおよび第２押圧部６９ｂが、それぞれ帯状体２０の帯状体遠位端部２２ａおよび帯状体近位端部２２ｂに接触することにより、帯状体２０およびカテーテルチューブ５に対する押圧が開始される。 In step S004 shown in FIG. 9, the strip 20 set in the groove 62 of the clamp base 61 is pressed toward the catheter tube 5. Specifically, as shown in FIG. 4, the clamp base 61 on which the catheter tube 5 coated with the adhesive is set in step S <b> 003 is fixed below the pressing portion 69 in the pressing device 60. Next, the operator of the pressing device 60 rotates the lever 65 shown in FIG. 4 to the front side to move the pressing force transmission member 68 and the pressing portion 69 connected to the lower end of the pressing force transmission member 68 downward. Move. Accordingly, the first pressing portion 69 a and the second pressing portion 69 b of the pressing portion 69 shown in FIG. 5 approach the groove portion 62 from the opening side of the groove portion 62. Further, as shown in FIG. 8, the first pressing portion 69a and the second pressing portion 69b come into contact with the strip-like body distal end portion 22a and the strip-like body proximal end portion 22b of the strip-like body 20, respectively, thereby causing the strip-like body. 20 and the pressing on the catheter tube 5 are started.
　図９に示すステップＳ００５では、図５に示す押圧装置６０の検出部７０が押圧力を検出し、検出結果を見ながら操作者が押圧力を調整する。図５に示す変形部７１は、押圧部６９による押圧が開始されると、押圧部６９が受ける反力が変形部７１に伝えられることにより上下方向に収縮し、押圧部６９による押圧力を検知する。また検出部７０は、変形部７１が変形することにより押圧力伝達部６８の下端６８ａと目盛り７２との相対位置が変化し、下端６８ａと目盛り７２との位置関係により押圧部６９による押圧力を表示する。 9, the detection unit 70 of the pressing device 60 illustrated in FIG. 5 detects the pressing force, and the operator adjusts the pressing force while viewing the detection result. When the pressing by the pressing portion 69 is started, the deforming portion 71 shown in FIG. 5 contracts in the vertical direction by the reaction force received by the pressing portion 69 being transmitted to the deforming portion 71 and detects the pressing force by the pressing portion 69. To do. The detecting unit 70 changes the relative position between the lower end 68a of the pressing force transmitting unit 68 and the scale 72 as the deforming unit 71 is deformed, and the pressing force by the pressing unit 69 is determined by the positional relationship between the lower end 68a and the scale 72. indicate.
　押圧装置６０の操作者は、目盛り７２による押圧力の表示内容を見ながら、押圧装置６０のレバー６５を操作することにより、押圧部６９が帯状体２０をカテーテルチューブ５に向かって押圧する押圧力を調整する。なお、ステップＳ００４またはステップＳ００５では、所定の押圧力で押圧部６９が帯状体２０をカテーテルチューブ５に向かって押圧する状態が、一定の時間継続されてもよい。所定の押圧力が維持される時間は、塗布された接着剤等に応じて適宜調整される。 The operator of the pressing device 60 operates the lever 65 of the pressing device 60 while observing the display content of the pressing force by the scale 72, so that the pressing portion 69 presses the strip 20 toward the catheter tube 5. Adjust. In step S004 or step S005, the state in which the pressing portion 69 presses the strip 20 toward the catheter tube 5 with a predetermined pressing force may be continued for a certain period of time. The time for which the predetermined pressing force is maintained is appropriately adjusted according to the applied adhesive or the like.
　図９に示すステップＳ００６では、帯状体２０とカテーテルチューブ５とを接着する接着剤を硬化させる。たとえば、ステップＳ００３で塗布した接着剤が湿気硬化型や溶剤揮発型である場合は、ステップＳ００５を終えた後のカテーテルチューブ５及び帯状体２０を、室内等の所定環境に放置することにより、接着剤を硬化させる。このように、図９に示す一連の工程により、図１～図３に示す偏心バルーンカテーテル１を得ることができる。 In step S006 shown in FIG. 9, the adhesive that bonds the strip 20 and the catheter tube 5 is cured. For example, when the adhesive applied in step S003 is a moisture-curing type or a solvent volatile type, the catheter tube 5 and the band-like body 20 after the completion of step S005 are left in a predetermined environment such as a room for adhesion. The agent is cured. As described above, the eccentric balloon catheter 1 shown in FIGS. 1 to 3 can be obtained by the series of steps shown in FIG.
　このように、図４に示すような押圧装置６０を用いて偏心バルーンカテーテル１を製造することにより、帯状体２０とカテーテルチューブ５との接合強度を安定させることができるため、適切な強度と信頼性を有する偏心バルーンカテーテル１を効率的に製造することができる。すなわち、押圧装置６０の検出部７０による押圧力の検出結果に基づき、帯状体２０とカテーテルチューブ５との接合工程における押圧力を適切な範囲に調整することにより、帯状体２０とカテーテルチューブ５との間に形成された隙間の広さや、帯状体２０とカテーテルチューブ５とを接合する接着剤硬化層の広がりを安定させることができるため、帯状体２０とカテーテルチューブ５との接合信頼性を高めることができる。 As described above, since the eccentric balloon catheter 1 is manufactured using the pressing device 60 as shown in FIG. 4, the bonding strength between the belt-like body 20 and the catheter tube 5 can be stabilized. The eccentric balloon catheter 1 having the characteristics can be efficiently manufactured. That is, based on the detection result of the pressing force by the detection unit 70 of the pressing device 60, by adjusting the pressing force in the joining process of the strip 20 and the catheter tube 5 to an appropriate range, the strip 20 and the catheter tube 5 Since the width of the gap formed between them and the spread of the cured adhesive layer that joins the strip 20 and the catheter tube 5 can be stabilized, the reliability of joining the strip 20 and the catheter tube 5 is improved. be able to.
　また、押圧装置６０は、押圧力を正確に調整可能であるため、第１押圧部６９ａと第２押圧部６９ｂにより２箇所同時に押圧した場合にでも、押圧力およびこれに関連する接合強度のばらつきを抑制することができるため、偏心バルーンカテーテル１を効率的に製造することができる。また、押圧装置６０は、図８に示すように、第１押圧部６９ａによる接合部分と第２押圧部６９ｂによる接合部分とで、造影リング２６ｂの有無などにより形状が異なる場合であっても、接合面間に適切に接着剤７８ａ、７８ｂを介在させ、偏心バルーンカテーテル１における帯状体２０の接合信頼性を高めることができる。 In addition, since the pressing device 60 can accurately adjust the pressing force, even when the first pressing portion 69a and the second pressing portion 69b are simultaneously pressed at two places, the pressing force and the variation in the bonding strength related thereto are varied. Therefore, the eccentric balloon catheter 1 can be manufactured efficiently. In addition, as shown in FIG. 8, the pressing device 60 may have different shapes depending on the presence or absence of the contrast ring 26 b between the joining portion formed by the first pressing portion 69 a and the joining portion formed by the second pressing portion 69 b. Adhesives 78a and 78b are appropriately interposed between the joining surfaces, and the joining reliability of the band-like body 20 in the eccentric balloon catheter 1 can be enhanced.
　図４～図６に示す押圧装置６０および押圧装置６０を用いた偏心バルーカテーテル１の製造方法は、本発明の一実施形態にすぎず、本発明には多くの他の実施形態が含まれることは言うまでもない。例えば、上述した偏心バルーンカテーテル１の製造方法では、帯状体２０をカテーテルチューブ５の外周面に接着したが、帯状体２０の接合方法はこれに限定されず、帯状体２０の一部又は全部がバルーン２に接合されていてもよい。また、上述の実施形態では、バルーン２の膨張を規制する膨張規制部材が帯状体２０であるが、膨張規制部材は帯状の帯状体２０に限定されず、線状、チューブ状等、他の形状であってもかまわない。 The manufacturing method of the eccentric balloon catheter 1 using the pressing device 60 and the pressing device 60 shown in FIGS. 4 to 6 is only one embodiment of the present invention, and the present invention includes many other embodiments. Needless to say. For example, in the manufacturing method of the eccentric balloon catheter 1 described above, the band 20 is bonded to the outer peripheral surface of the catheter tube 5, but the bonding method of the band 20 is not limited to this, and a part or all of the band 20 is formed. It may be joined to the balloon 2. In the above-described embodiment, the expansion regulating member that regulates the inflation of the balloon 2 is the band-shaped body 20, but the expansion regulating member is not limited to the band-shaped band-shaped body 20, and other shapes such as a linear shape, a tube shape, and the like. It doesn't matter.
　また、実施形態で示した押圧装置６０の検出部７０は、変形部７１としての圧縮バネを有するが、検出部７０が有する変形部７１としてはこれに限定されず、空気圧バネ、油圧バネのような他のバネを採用することができる。また、表示部は、図２に示すような目盛り７２を有するものに限定されず、ランプや液晶パネルのような電気的な表示手段や、圧力ゲージのような機械式の表示手段であってもよい。なお、押圧装置は、機械的な変形量を電気信号に変換する圧力センサを、検出部７０の変形部として採用してもよい。 Moreover, although the detection part 70 of the press apparatus 60 shown by embodiment has a compression spring as the deformation | transformation part 71, as the deformation | transformation part 71 which the detection part 70 has, it is not limited to this, Like a pneumatic spring and a hydraulic spring Other springs can be employed. The display unit is not limited to the one having the scale 72 as shown in FIG. 2, and may be an electric display unit such as a lamp or a liquid crystal panel, or a mechanical display unit such as a pressure gauge. Good. Note that the pressure device may employ a pressure sensor that converts a mechanical deformation amount into an electric signal as the deformation portion of the detection unit 70.
　また、押圧装置６０及びこれを用いた製造方法によって製造される偏心バルーンカテーテル１は、胆管から胆石を除去する胆石除去用の偏心バルーンカテーテルに限定されず、胆石以外の結石その他を移動させたり、除去したりする偏心バルーンカテーテルや、その他の偏心バルーンカテーテルであってもよい。 Further, the eccentric balloon catheter 1 manufactured by the pressing device 60 and the manufacturing method using the pressing device 60 is not limited to the eccentric balloon catheter for removing gallstones from the bile duct, and moves stones other than gallstones, An eccentric balloon catheter to be removed or other eccentric balloon catheter may be used.
　以下、実施例を示して、本発明を更に詳細に説明するが、本発明の技術的範囲はこれらの実施形態に限定されるものではない。 Hereinafter, the present invention will be described in more detail with reference to examples. However, the technical scope of the present invention is not limited to these embodiments.
　図４に示す押圧装置６０を用いて、図９に示すフローチャートに従って偏心バルーンカテーテル１を作製したのち、接着後の帯状体２０をカテーテルチューブ５から引き剥がす引き剥がし試験を行い、接着強度のばらつきを調査した。引き剥がし試験を行った試料Ｎｏ．１～Ｎｏ．２０は、カテーテルチューブ５、バルーン２、帯状体２０の材質及び寸法、カテーテルチューブ５に帯状体２０を固定する接着剤の種類及び塗布量については同様である。すべての試料で共通の条件を以下に示す。 After producing the eccentric balloon catheter 1 according to the flowchart shown in FIG. 9 using the pressing device 60 shown in FIG. 4, a peeling test is performed to peel the band-like body 20 after bonding from the catheter tube 5, and variations in bonding strength are observed. investigated. Sample No. for which the peel test was conducted 1-No. No. 20 is the same for the material and dimensions of the catheter tube 5, balloon 2, and strip 20, and the type and amount of adhesive that secures the strip 20 to the catheter tube 5. Conditions common to all samples are shown below.
　カテーテルチューブ：材質　ナイロン系エラストマー、外径１．８０～１．９０ｍｍ、長さ１９５０～２１５０ｍｍ
　バルーン：材質　天然ゴムラテックス　、収縮時外径２．１４～２．３０ｍｍ、長さ１０．５～１１．５ｍｍ、膜厚０．１７～０．２５ｍｍ
　帯状体：材質　ナイロン系エラストマー、長さ１３．５～１４．５ｍｍ、幅１．３～１．７ｍｍ、厚み０．１５～０．２５ｍｍ
　接着剤：種類　シアノアクリレート系接着剤、塗布量１～２滴（帯状体遠位端部２２ａまたは帯状体近位端部２２ｂ１カ所あたり） Catheter tube: Material nylon elastomer, outer diameter 1.80 to 1.90 mm, length 1950 to 2150 mm
Balloon: Material Natural rubber latex, outer diameter 2.14 to 2.30 mm when contracted, length 10.5 to 11.5 mm, film thickness 0.17 to 0.25 mm
Strip: Material Nylon elastomer, length 13.5 to 14.5 mm, width 1.3 to 1.7 mm, thickness 0.15 to 0.25 mm
Adhesive: Type Cyanoacrylate adhesive, 1 to 2 drops (per 1 band distal end 22a or band proximal end 22b)
　引き剥がし試験のために作製した試料Ｎｏ．１～Ｎｏ．２０は、図９におけるステップＳ００５で行われる帯状体２０のカテーテルチューブ５への押圧力を、表１に示す三水準で変化させて作製した。なお、各試料の製造において、ステップＳ００５では、表１に示す水準に押圧力を調整したのち、３０～５０秒程度その押圧力を維持した。
Figure JPOXMLDOC01-appb-T000001
 Sample No. prepared for the peeling test. 1-No. No. 20 was produced by changing the pressing force of the strip 20 on the catheter tube 5 performed in step S005 in FIG. 9 at three levels shown in Table 1. In the production of each sample, in step S005, after adjusting the pressing force to the level shown in Table 1, the pressing force was maintained for about 30 to 50 seconds.
Figure JPOXMLDOC01-appb-T000001
　引き剥がし試験では、まず、帯状体２０を中央で切断することにより、１つの偏心バルーンカテーテル１から、接着位置が帯状体遠位端部２２ａである試料と、接着位置が帯状体近位端部２２ｂである試料の２つを作製した。さらに、切断した帯状体２０の端部をロードセルに固定し、カテーテルチューブ５を可動テーブルに固定したうえで可動テーブルを動かすことで帯状体２０を引っ張り、帯状体２０の引張距離と加重の関係を測定した。引き剥がし試験には、レオメータ（株式会社レオテック社製）を用いた。 In the peeling test, first, the band 20 is cut at the center, thereby from one eccentric balloon catheter 1, a sample whose bonding position is the band-shaped distal end 22a, and a bonding position that is the proximal end of the band-shaped body. Two of the samples, 22b, were made. Furthermore, the end of the cut strip 20 is fixed to the load cell, the catheter tube 5 is fixed to the movable table, and the movable table is moved to pull the strip 20, and the relationship between the tensile distance and the weight of the strip 20 is determined. It was measured. For the peel test, a rheometer (manufactured by Rheotech Co., Ltd.) was used.
　図１０は、押圧装置６０による押圧力が水準１（４．８９Ｎ）である試料Ｎｏ．１～Ｎｏ．６までの引き剥がし試験の結果を表すグラフである。この水準では、６試料中１試料（試料Ｎｏ．１）で、破断前に帯状体２０が引き伸ばされる過程が見られず、接合不良が確認された。 FIG. 10 shows a sample No. 1 in which the pressing force by the pressing device 60 is level 1 (4.89 N). 1-No. It is a graph showing the result of the peeling test to 6. At this level, in one of the six samples (sample No. 1), the process of stretching the band-like body 20 before rupture was not observed, and poor bonding was confirmed.
　図１１は、押圧装置６０におる押圧力が水準２（６．９４Ｎ）である試料Ｎｏ．７～Ｎｏ．１２までの引き剥がし試験の結果を表すグラフである。この水準では、いずれの試料でも接合不良は確認されなかった。 FIG. 11 shows a sample No. 2 in which the pressing force in the pressing device 60 is level 2 (6.94 N). 7-No. It is a graph showing the result of the peeling test to 12. At this level, no bonding failure was confirmed in any of the samples.
　図１２は、押圧装置６０による押圧力が水準３（９．０３Ｎ）である試料Ｎｏ．１３～
Ｎｏ．２０までの引き剥がし試験の結果を表すグラフである。この水準では、８試料中４試料（試料Ｎｏ．１５、Ｎｏ．１８～Ｎｏ．２０）で、破断前に帯状体２０が引き伸ばされる過程が見られず、接合不良が確認された。 12 shows a sample No. 2 in which the pressing force by the pressing device 60 is level 3 (9.03 N). 13 ~
No. It is a graph showing the result of the peeling test to 20. At this level, 4 of 8 samples (samples No. 15, No. 18 to No. 20) did not show a process of stretching the band-like body 20 before breaking, and a bonding failure was confirmed.
　図１０～図１２に示す引き剥がし試験の結果から、帯状体２０をカテーテルチューブ５に接着する工程において、押圧装置６０を用いて押圧力が所定の範囲（たとえば、水準２の周辺や、または水準１から水準２の範囲）になるように管理しながら偏心バルーンカテーテル１の製造を行うことにより、帯状体２０とカテーテルチューブ５との接合強度を、十分な強度を確保できる水準で安定させられることを確認できた。また、押圧装置６０を用いて押圧力を管理しながら偏心バルーンカテーテル１の製造を行うことにより、帯状体２０とカテーテルチューブ５との接合不良に伴う不良品の発生を抑制し、効率的な製造が可能になると考えられる。 From the results of the peeling test shown in FIGS. 10 to 12, in the step of bonding the strip 20 to the catheter tube 5, the pressing force is within a predetermined range (for example, around the level 2 or the level). By manufacturing the eccentric balloon catheter 1 while managing so as to be within the range of 1 to level 2, the bonding strength between the belt-like body 20 and the catheter tube 5 can be stabilized at a level that can ensure sufficient strength. Was confirmed. In addition, by manufacturing the eccentric balloon catheter 1 while controlling the pressing force using the pressing device 60, it is possible to suppress the generation of defective products due to the bonding failure between the belt-like body 20 and the catheter tube 5, and to efficiently manufacture the eccentric balloon catheter 1. Will be possible.
　１…偏心バルーンカテーテル
　２…バルーン
　３…膨張部
　４ａ、４ｂ…接合部
　５…カテーテルチューブ
　７…チューブ遠位端部
　２０…帯状体
　２２ａ…帯状体遠位端部
　２２ｂ…帯状体近位端部
　２４…内部空間
　２６ａ、２６ｂ…造影リング
　５０…結石
　６０…押圧装置
　６１…クランプ台
　６２…溝部
　６３…固定板
　６４…台座
　６５…レバー
　６６…支柱
　６７…梁
　６８…押圧力伝達部
　６９…押圧部
　６９ａ…第１押圧部
　６９ｂ…第２押圧部
　７０…検出部
　７１…変形部
　７２…目盛り
　７８ａ、７８ｂ…接着剤 DESCRIPTION OF SYMBOLS 1 ... Eccentric balloon catheter 2 ... Balloon 3 ... Expansion part 4a, 4b ... Junction part 5 ... Catheter tube 7 ... Tube distal end part 20 ... Band-shaped body 22a ... Band-shaped body distal end part 22b ... Band-shaped body proximal end part 24 ... Internal space 26a, 26b ... Contrast ring 50 ... Stone 60 ... Pressing device 61 ... Clamp base 62 ... Groove 63 ... Fixing plate 64 ... Base 65 ... Lever 66 ... Post 67 ... Beam 68 ... Pressing force transmitting part 69 ... Pressing part 69a ... 1st press part 69b ... 2nd press part 70 ... Detection part 71 ... Deformation part 72 ... Scale 78a, 78b ... Adhesive

Claims (7)

  1. 　バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルの製造装置であって、
    　前記カテーテルチューブと、前記カテーテルチューブが挿通および接合した前記バルーンと、少なくとも一部が前記バルーンに重なるように前記カテーテルチューブおよび前記バルーンの上に配置されており前記バルーンが膨張する際において前記バルーンの周方向の一部が前記カテーテルチューブから離間することを規制する膨張規制部材と、を収容する溝部が形成されているクランプ台と、
    　前記溝部の開口側から前記溝部に対して近接および離間するように相対移動可能であって、前記膨張規制部材を前記カテーテルチューブに向かって押圧する押圧部と、
    　前記押圧部による押圧力を検出する検出部と、を有する偏心バルーンカテーテルの製造装置。     An apparatus for manufacturing an eccentric balloon catheter in which a balloon is eccentric and expands with respect to the axis of a catheter tube,
    The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon. An expansion restricting member that restricts a part of the circumferential direction from being separated from the catheter tube;
    A pressing part that is movable relative to and away from the groove part from the opening side of the groove part, and that presses the expansion regulating member toward the catheter tube;
    An eccentric balloon catheter manufacturing apparatus, comprising: a detection unit that detects a pressing force by the pressing unit.
  2. 　前記押圧部は、前記溝部の延びる方向に沿って所定の間隔を空けて配列されており、前記バルーンより遠位端側において前記膨張規制部材を前記カテーテルチューブに向かって押圧する第１押圧部と、前記バルーンより近位端側において前記膨張規制部材を前記カテーテルチューブに向かって押圧する第２押圧部と、を有する請求項１に記載の偏心バルーンカテーテルの製造装置。 The pressing portion is arranged at a predetermined interval along the extending direction of the groove portion, and a first pressing portion that presses the expansion regulating member toward the catheter tube on a distal end side from the balloon. The manufacturing apparatus of the eccentric balloon catheter according to claim 1, further comprising: a second pressing portion that presses the expansion regulating member toward the catheter tube at a proximal end side from the balloon.
  3. 　前記検出部は、前記押圧部と前記押圧部に押圧力を伝える押圧力伝達部との間に配置されており、前記押圧部から伝えられる反力に応じて前記押圧部の相対移動方向に変形する変形部と、前記変形部の変形量に対応する前記押圧部の押圧力を表示する表示部と、を有する請求項１または請求項２に記載の偏心バルーンカテーテルの製造装置。 The detection unit is disposed between the pressing unit and a pressing force transmission unit that transmits a pressing force to the pressing unit, and is deformed in a relative movement direction of the pressing unit according to a reaction force transmitted from the pressing unit. The manufacturing apparatus of the eccentric balloon catheter of Claim 1 or Claim 2 which has a display part which displays the deformation | transformation part to perform, and the pressing force of the said press part corresponding to the deformation amount of the said deformation | transformation part.
  4. 　前記変形部は、圧縮バネを有することを特徴とする請求項３に記載の偏心バルーンカテーテルの製造装置。 4. The eccentric balloon catheter manufacturing apparatus according to claim 3, wherein the deforming portion includes a compression spring.
  5. 　前記変形部は、空気圧バネを有することを特徴とする請求項３に記載の偏心バルーンカテーテルの製造装置。 4. The eccentric balloon catheter manufacturing apparatus according to claim 3, wherein the deforming portion includes a pneumatic spring.
  6. 　前記変形部は、油圧バネを有することを特徴とする請求項３に記載の偏心バルーンカテーテルの製造装置。 4. The eccentric balloon catheter manufacturing apparatus according to claim 3, wherein the deforming portion includes a hydraulic spring.
  7. 　バルーンがカテーテルチューブの軸心に対して偏芯して膨らむ偏心バルーンカテーテルの製造方法であって、
    　前記カテーテルチューブと、前記カテーテルチューブが挿通および接合した前記バルーンと、少なくとも一部が前記バルーンに重なるように前記カテーテルチューブおよび前記バルーンの上に配置されており前記バルーンが膨張する際において前記バルーンの周方向の一部が前記カテーテルチューブから離間することを規制する膨張規制部材とを、クランプ台に形成された溝部に配置する工程と、
    　前記膨張規制部材とカテーテルチューブとの間に接着剤を塗布する工程と、
    　前記溝部の開口側から前記クランプ台の前記溝部に対して近接および離間するように相対移動可能な押圧部によって、前記膨張規制部材を前記カテーテルチューブに向かって押圧する工程と、
    　前記押圧部による押圧力を検出部が検出する工程と、
    　前記検出部による検出結果に基づき前記押圧部による押圧力を調整する工程と、を有する偏心バルーンカテーテルの製造方法。     A method of manufacturing an eccentric balloon catheter in which a balloon is eccentrically inflated with respect to an axis of a catheter tube,
    The catheter tube, the balloon through which the catheter tube is inserted and joined, and the catheter tube and the balloon are arranged so that at least a part thereof overlaps the balloon. A step of disposing an expansion regulating member that regulates separation of a part of the circumferential direction from the catheter tube in a groove formed in the clamp table;
    Applying an adhesive between the expansion regulating member and the catheter tube;
    A step of pressing the expansion regulating member toward the catheter tube by a pressing portion that is relatively movable so as to approach and separate from the groove portion of the clamp base from the opening side of the groove portion;
    A step of detecting a pressing force by the pressing unit by the detecting unit;
    And a step of adjusting a pressing force by the pressing portion based on a detection result by the detecting portion.
PCT/JP2017/006368 2016-03-18 2017-02-21 Apparatus for producing eccentric balloon catheter and method for producing eccentric balloon catheter WO2017159234A1 (en)

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